Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 12 of 42 for:    Malignant Hyperthermia 5

A Study of Dalotuzumab + MK-2206, Dalotuzumab + MK-0752, and Dalotuzumab + Ridaforolimus Combination Therapies in Participants With Advanced Cancer (MK-0646-027)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01243762
Recruitment Status : Terminated (The study was terminated for business reasons and not due to any safety or efficacy concerns related to dalotuzumab.)
First Posted : November 19, 2010
Results First Posted : October 30, 2017
Last Update Posted : August 16, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Neoplasms Malignant
Interventions Drug: dalotuzumab
Drug: MK-0752
Drug: ridaforolimus
Drug: MK-2206
Enrollment 47
Recruitment Details  
Pre-assignment Details 41 participants enrolled in Part 1 (dose escalation/preliminary maximum tolerated dose [MTD] identification). 12 participants continued in Part 2 (preliminary anti-tumor activity assessment), and 6 new participants were enrolled in Part 2 that did not participate in Part 1 (total enrollment = 47). Study terminated prior to completion of Part 2.
Arm/Group Title Dalotuzumab 7.5 mg/kg + MK-0752 1800 mg Dalotuzumab 10 mg/kg + MK-0752 1800 mg Dalotuzumab 10 mg/kg + MK-2206 90 mg Dalotuzumab 10 mg/kg + MK-2206 135 mg Dalotuzumab 10 mg/kg + MK-2206 150 mg Dalotuzumab 10 mg/kg + MK-2206 200 mg Dalotuzumab + Ridaforolimus
Hide Arm/Group Description Participants received dalotuzumab 7.5 mg/kg IV weekly + MK-0752 1800 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation. Participants received dalotuzumab 10 mg/kg IV weekly + MK-0752 1800 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation. Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 90 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation. Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 135 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation. Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 150 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation. Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 200 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation. Participants received dalotuzumab 10 mg/kg IV weekly + ridaforolimus 20 mg PO daily for 5 consecutive days per week in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
Period Title: Part 1 (Dose Escalation/MTD)
Started 4 13 3 8 10 3 0
Completed 1 [1] 5 [1] 0 2 [1] 4 [1] 0 0
Not Completed 3 8 3 6 6 3 0
Reason Not Completed
Adverse Event             0             2             0             0             1             1             0
Physician Decision             0             1             0             1             0             0             0
Progressive Disease             3             2             3             5             5             2             0
Withdrawal by Subject             0             3             0             0             0             0             0
[1]
Entered Part 2 of Study
Period Title: Part 2 (Dose Confirmation/Efficacy)
Started 1 5 0 2 4 0 6 [1]
Completed 0 0 0 0 0 0 0
Not Completed 1 5 0 2 4 0 6
Reason Not Completed
Adverse Event             0             1             0             0             0             0             3
Progressive Disease             1             3             0             1             2             0             3
Withdrawal by Subject             0             1             0             0             1             0             0
Physician Decision             0             0             0             1             1             0             0
[1]
New participants were enrolled in Part 2 of the study that did not participate in Part 1
Arm/Group Title Dalotuzumab 7.5 mg/kg + MK-0752 1800 mg Dalotuzumab 10 mg/kg + MK-0752 1800 mg Dalotuzumab 10 mg/kg + MK-2206 90 mg Dalotuzumab 10 mg/kg + MK-2206 135 mg Dalotuzumab 10 mg/kg + MK-2206 150 mg Dalotuzumab 10 mg/kg + MK-2206 200 mg Dalotuzumab + Ridaforolimus Total
Hide Arm/Group Description Participants received dalotuzumab 7.5 mg/kg IV weekly + MK-0752 1800 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation. Participants received dalotuzumab 10 mg/kg IV weekly + MK-0752 1800 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation. Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 90 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation. Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 135 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation. Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 150 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation. Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 200 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation. Participants received dalotuzumab 10 mg/kg IV weekly + ridaforolimus 20 mg PO daily for 5 consecutive days per week in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation. Total of all reporting groups
Overall Number of Baseline Participants 4 13 3 8 10 3 6 47
Hide Baseline Analysis Population Description
Total number of participants for each dose combination for the overall study
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 13 participants 3 participants 8 participants 10 participants 3 participants 6 participants 47 participants
51.8  (4.6) 59.0  (12.2) 50.3  (12.7) 60.4  (12.0) 65.4  (7.0) 57.3  (10.1) 68.8  (14.1) 60.6  (11.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 13 participants 3 participants 8 participants 10 participants 3 participants 6 participants 47 participants
Female
3
  75.0%
11
  84.6%
2
  66.7%
4
  50.0%
4
  40.0%
3
 100.0%
6
 100.0%
33
  70.2%
Male
1
  25.0%
2
  15.4%
1
  33.3%
4
  50.0%
6
  60.0%
0
   0.0%
0
   0.0%
14
  29.8%
1.Primary Outcome
Title Number of Participants With Dose-limiting Toxicities (DLTs)
Hide Description DLTs were defined as follows: 1) non-hematological toxicity ≥Grade 3 according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 except for Grade 3 nausea, vomiting, diarrhea, and/or dehydration; Grade 3 or 4 hyperglycemia; alopecia; inadequately treated hypersensitivity reactions; dalotuzumab infusion-related reactions; Grade 3 transaminases ≤1 week in duration; or clinically non-significant, treatable or reversible lab abnormalities; 2) Grade 4-5 hematologic toxicity, with the exception of Grade 4 neutropenia <6 days in duration; 3) Grade 3 or Grade 4 neutropenia with fever >38.5 degrees C; 4) Grade 4 thrombocytopenia ≤25.0 x 10^9/Liter; 5) drug-related adverse experience leading to a dose modification during Cycle 1; 6) unresolved drug-related toxicity that causes ≥3 week delay of the next scheduled dose of study medication; 7) persistent increases in QTc interval >60 milliseconds from baseline, or clinically significant bradycardia.
Time Frame Cycle 1-28 Days
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who completed the first cycle of study therapy or discontinued from the study due to a DLT attributable to study therapy.
Arm/Group Title Dalotuzumab 7.5 mg/kg + MK-0752 1800 mg Dalotuzumab 10 mg/kg + MK-0752 1800 mg Dalotuzumab 10 mg/kg + MK-2206 90 mg Dalotuzumab 10 mg/kg + MK-2206 135 mg Dalotuzumab 10 mg/kg + MK-2206 150 mg Dalotuzumab 10 mg/kg + MK-2206 200 mg Dalotuzumab + Ridaforolimus
Hide Arm/Group Description:
Participants received dalotuzumab 7.5 mg/kg IV weekly + MK-0752 1800 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
Participants received dalotuzumab 10 mg/kg IV weekly + MK-0752 1800 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 90 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 135 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 150 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 200 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
Participants received dalotuzumab 10 mg/kg IV weekly + ridaforolimus 20 mg PO daily for 5 consecutive days per week in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
Overall Number of Participants Analyzed 4 13 3 8 10 3 3
Measure Type: Number
Unit of Measure: Participants
1 3 0 1 3 2 0
2.Secondary Outcome
Title Number of Participants Whose Best Response is a Partial Response (PR) or Complete Response (CR)
Hide Description Best response was determined for the maximum tolerated dose from the start of treatment until disease progression, recurrence, or completion of 6 months of treatment. Lesions were measured by computed tomography (CT) scan or magnetic resonance imaging (MRI). Partial response (PR), defined as a tumor burden decrease of 30%, or complete response (CR) was determined using Response Criteria in Solid Tumors (RECIST) 1.1 for participants with at least one measurable target lesion at baseline.
Time Frame Up to 7 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study therapy and had baseline data for those analyses that required baseline data. The analysis was planned to be performed on the 3 arms in Part 2 only. The study was terminated prior to completion of this analysis.
Arm/Group Title Dalotuzumab 10 mg/kg + MK-0752 1800 mg Dalotuzumab 10 mg/kg + MK-2206 150 mg Dalotuzumab + Ridaforolimus
Hide Arm/Group Description:
Participants received dalotuzumab 10 mg/kg IV weekly + MK-0752 1800 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 150 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
Participants received dalotuzumab 10 mg/kg IV weekly + ridaforolimus 20 mg PO daily for 5 consecutive days per week in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
Overall Number of Participants Analyzed 6 6 6
Measure Type: Number
Unit of Measure: Participants
0 0 0
Time Frame Up to 7 months
Adverse Event Reporting Description Adverse events collected for all participants who received at least one dose of study therapy
 
Arm/Group Title Dalotuzumab 7.5 mg/kg + MK-0752 1800 mg Dalotuzumab 10 mg/kg + MK-0752 1800 mg Dalotuzumab 10 mg/kg + MK-2206 90 mg Dalotuzumab 10 mg/kg + MK-2206 135 mg Dalotuzumab 10 mg/kg + MK-2206 150 mg Dalotuzumab 10 mg/kg + MK-2206 200 mg Dalotuzumab + Ridaforolimus
Hide Arm/Group Description Participants received dalotuzumab 7.5 mg/kg IV weekly + MK-0752 1800 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation. Participants received dalotuzumab 10 mg/kg IV weekly + MK-0752 1800 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation. Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 90 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation. Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 135 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation. Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 150 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation. Participants received dalotuzumab 10 mg/kg IV weekly + MK-2206 200 mg PO weekly in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation. Participants received dalotuzumab 10 mg/kg IV weekly + ridaforolimus 20 mg PO daily for 5 consecutive days per week in 28-day cycles for a minimum of 6 cycles until disease progression or study discontinuation.
All-Cause Mortality
Dalotuzumab 7.5 mg/kg + MK-0752 1800 mg Dalotuzumab 10 mg/kg + MK-0752 1800 mg Dalotuzumab 10 mg/kg + MK-2206 90 mg Dalotuzumab 10 mg/kg + MK-2206 135 mg Dalotuzumab 10 mg/kg + MK-2206 150 mg Dalotuzumab 10 mg/kg + MK-2206 200 mg Dalotuzumab + Ridaforolimus
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Dalotuzumab 7.5 mg/kg + MK-0752 1800 mg Dalotuzumab 10 mg/kg + MK-0752 1800 mg Dalotuzumab 10 mg/kg + MK-2206 90 mg Dalotuzumab 10 mg/kg + MK-2206 135 mg Dalotuzumab 10 mg/kg + MK-2206 150 mg Dalotuzumab 10 mg/kg + MK-2206 200 mg Dalotuzumab + Ridaforolimus
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/4 (50.00%)      6/13 (46.15%)      0/3 (0.00%)      3/8 (37.50%)      6/10 (60.00%)      3/3 (100.00%)      5/6 (83.33%)    
Blood and lymphatic system disorders               
Anaemia  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0
Neutropenia  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0
Cardiac disorders               
Atrial fibrillation  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0
Pericardial effusion  1  0/4 (0.00%)  0 1/13 (7.69%)  1 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Gastrointestinal disorders               
Abdominal pain upper  1  0/4 (0.00%)  0 1/13 (7.69%)  1 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Colonic obstruction  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1
Constipation  1  0/4 (0.00%)  0 1/13 (7.69%)  1 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Diarrhoea  1  1/4 (25.00%)  1 1/13 (7.69%)  1 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Gastrointestinal haemorrhage  1  0/4 (0.00%)  0 1/13 (7.69%)  1 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Gastrointestinal inflammation  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0
Intestinal perforation  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Nausea  1  0/4 (0.00%)  0 1/13 (7.69%)  1 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Small intestinal obstruction  1  0/4 (0.00%)  0 1/13 (7.69%)  1 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Small intestinal perforation  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1
Vomiting  1  0/4 (0.00%)  0 1/13 (7.69%)  1 0/3 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0
General disorders               
General physical health deterioration  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0
Hepatobiliary disorders               
Bile duct obstruction  1  0/4 (0.00%)  0 1/13 (7.69%)  1 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Infections and infestations               
Device related infection  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Infectious peritonitis  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1
Pneumonia  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1
Postoperative wound infection  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1
Urinary tract infection  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0
Injury, poisoning and procedural complications               
Infusion related reaction  1  1/4 (25.00%)  1 1/13 (7.69%)  1 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Investigations               
Electrocardiogram QT prolonged  1  1/4 (25.00%)  1 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Electrocardiogram T wave inversion  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1
Metabolism and nutrition disorders               
Dehydration  1  0/4 (0.00%)  0 2/13 (15.38%)  2 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Hypokalaemia  1  1/4 (25.00%)  1 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Hypophosphataemia  1  1/4 (25.00%)  1 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)               
Malignant neoplasm progression  1  0/4 (0.00%)  0 1/13 (7.69%)  1 0/3 (0.00%)  0 1/8 (12.50%)  1 1/10 (10.00%)  1 1/3 (33.33%)  1 3/6 (50.00%)  3
Renal and urinary disorders               
Urinary retention  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0
Respiratory, thoracic and mediastinal disorders               
Pneumonitis  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1
Vascular disorders               
Deep vein thrombosis  1  0/4 (0.00%)  0 1/13 (7.69%)  1 0/3 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dalotuzumab 7.5 mg/kg + MK-0752 1800 mg Dalotuzumab 10 mg/kg + MK-0752 1800 mg Dalotuzumab 10 mg/kg + MK-2206 90 mg Dalotuzumab 10 mg/kg + MK-2206 135 mg Dalotuzumab 10 mg/kg + MK-2206 150 mg Dalotuzumab 10 mg/kg + MK-2206 200 mg Dalotuzumab + Ridaforolimus
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/4 (100.00%)      13/13 (100.00%)      3/3 (100.00%)      8/8 (100.00%)      10/10 (100.00%)      3/3 (100.00%)      6/6 (100.00%)    
Blood and lymphatic system disorders               
Anaemia  1  1/4 (25.00%)  1 3/13 (23.08%)  3 0/3 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 1/3 (33.33%)  1 3/6 (50.00%)  5
Leukopenia  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 1/3 (33.33%)  2 0/6 (0.00%)  0
Lymphopenia  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1
Neutropenia  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 1/3 (33.33%)  2 0/6 (0.00%)  0
Thrombocytopenia  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 1/3 (33.33%)  1 3/6 (50.00%)  3
Cardiac disorders               
Tachycardia  1  0/4 (0.00%)  0 1/13 (7.69%)  1 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0
Ear and labyrinth disorders               
Ear discomfort  1  0/4 (0.00%)  0 2/13 (15.38%)  2 0/3 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0
Hearing impaired  1  0/4 (0.00%)  0 1/13 (7.69%)  1 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Middle ear effusion  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0
Tinnitus  1  0/4 (0.00%)  0 1/13 (7.69%)  1 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Vertigo  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0
Eye disorders               
Dry eye  1  1/4 (25.00%)  1 0/13 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 0/10 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1
Orbital oedema  1  1/4 (25.00%)  1 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Photophobia  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0
Photopsia  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0
Vision blurred  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0
Vitreous floaters  1  0/4 (0.00%)  0 0/13 (0.00%)  0 1/3 (33.33%)  2 0/8 (0.00%)  0 1/10 (10.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0
Gastrointestinal disorders               
Abdominal distension  1  2/4 (50.00%)  2 1/13 (7.69%)  1 0/3 (0.00%)  0 1/8 (12.50%)  2 0/10 (0.00%)  0 0/3 (0.00%)  0 2/6 (33.33%)  2
Abdominal pain  1  3/4 (75.00%)  3 1/13 (7.69%)  1 1/3 (33.33%)  1 2/8 (25.00%)  2 5/10 (50.00%)  5 1/3 (33.33%)  1 2/6 (33.33%)  2
Abdominal pain lower  1  0/4 (0.00%)  0 0/13 (0.00%)  0 1/3 (33.33%)  1 0/8 (0.00%)  0 1/10 (10.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0
Abdominal pain upper  1  0/4 (0.00%)  0 1/13 (7.69%)  1 1/3 (33.33%)  1 1/8 (12.50%)  1 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Anal fissure  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Ascites  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 2/10 (20.00%)  4 0/3 (0.00%)  0 1/6 (16.67%)  1
Constipation  1  2/4 (50.00%)  2 1/13 (7.69%)  1 2/3 (66.67%)  2 1/8 (12.50%)  2 4/10 (40.00%)  4 0/3 (0.00%)  0 3/6 (50.00%)  3
Diarrhoea  1  3/4 (75.00%)  5 5/13 (38.46%)  7 1/3 (33.33%)  1 4/8 (50.00%)  5 4/10 (40.00%)  4 1/3 (33.33%)  1 3/6 (50.00%)  6
Dry mouth  1  1/4 (25.00%)  1 0/13 (0.00%)  0 1/3 (33.33%)  1 1/8 (12.50%)  1 3/10 (30.00%)  3 1/3 (33.33%)  1 2/6 (33.33%)  2
Duodenal stenosis  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1
Dyspepsia  1  0/4 (0.00%)  0 2/13 (15.38%)  2 0/3 (0.00%)  0 1/8 (12.50%)  1 1/10 (10.00%)  1 0/3 (0.00%)  0 1/6 (16.67%)  1
Dysphagia  1  0/4 (0.00%)  0 1/13 (7.69%)  1 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Flatulence  1  1/4 (25.00%)  1 1/13 (7.69%)  1 0/3 (0.00%)  0 1/8 (12.50%)  1 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Gastritis  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1
Gastrooesophageal reflux disease  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Gingival pain  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0
Haematemesis  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0
Melaena  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0
Nausea  1  3/4 (75.00%)  3 10/13 (76.92%)  10 1/3 (33.33%)  2 4/8 (50.00%)  5 3/10 (30.00%)  3 2/3 (66.67%)  4 1/6 (16.67%)  1
Oesophageal pain  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1
Oesophageal ulcer  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1
Oesophagitis  1  1/4 (25.00%)  1 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1
Oral pain  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 1/10 (10.00%)  1 0/3 (0.00%)  0 1/6 (16.67%)  1
Proctalgia  1  0/4 (0.00%)  0 1/13 (7.69%)  1 0/3 (0.00%)  0 1/8 (12.50%)  1 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Rectal haemorrhage  1  1/4 (25.00%)  1 0/13 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  2 1/10 (10.00%)  1 0/3 (0.00%)  0 1/6 (16.67%)  1
Rectal tenesmus  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  2
Sensitivity of teeth  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0
Stomatitis  1  0/4 (0.00%)  0 2/13 (15.38%)  4 0/3 (0.00%)  0 0/8 (0.00%)  0 3/10 (30.00%)  7 0/3 (0.00%)  0 3/6 (50.00%)  3
Vomiting  1  3/4 (75.00%)  4 7/13 (53.85%)  7 1/3 (33.33%)  1 2/8 (25.00%)  2 3/10 (30.00%)  3 0/3 (0.00%)  0 3/6 (50.00%)  4
General disorders               
Asthenia  1  0/4 (0.00%)  0 2/13 (15.38%)  3 0/3 (0.00%)  0 1/8 (12.50%)  1 2/10 (20.00%)  5 0/3 (0.00%)  0 2/6 (33.33%)  2
Catheter site pain  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1
Chest pain  1  1/4 (25.00%)  1 0/13 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Chills  1  2/4 (50.00%)  2 0/13 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  2 1/10 (10.00%)  1 1/3 (33.33%)  1 0/6 (0.00%)  0
Fatigue  1  3/4 (75.00%)  4 9/13 (69.23%)  9 1/3 (33.33%)  2 6/8 (75.00%)  7 8/10 (80.00%)  10 3/3 (100.00%)  4 3/6 (50.00%)  3
Gait disturbance  1  1/4 (25.00%)  1 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Implant site haemorrhage  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1
Infusion site extravasation  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 0/10 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1
Localised oedema  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0
Mucosal inflammation  1  0/4 (0.00%)  0 1/13 (7.69%)  1 1/3 (33.33%)  1 2/8 (25.00%)  3 0/10 (0.00%)  0 1/3 (33.33%)  1 2/6 (33.33%)  2
Oedema  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 2/8 (25.00%)  2 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Oedema peripheral  1  3/4 (75.00%)  3 1/13 (7.69%)  1 0/3 (0.00%)  0 2/8 (25.00%)  2 2/10 (20.00%)  2 1/3 (33.33%)  1 0/6 (0.00%)  0
Pain  1  0/4 (0.00%)  0 2/13 (15.38%)  2 0/3 (0.00%)  0 1/8 (12.50%)  1 1/10 (10.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0
Pyrexia  1  1/4 (25.00%)  1 0/13 (0.00%)  0 0/3 (0.00%)  0 2/8 (25.00%)  3 2/10 (20.00%)  2 2/3 (66.67%)  2 2/6 (33.33%)  3
Secretion discharge  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1
Hepatobiliary disorders               
Hyperbilirubinaemia  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1
Jaundice  1  0/4 (0.00%)  0 2/13 (15.38%)  2 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Immune system disorders               
Hypersensitivity  1  0/4 (0.00%)  0 1/13 (7.69%)  1 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Serum sickness-like reaction  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Infections and infestations               
Abdominal infection  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1
Cellulitis  1  1/4 (25.00%)  1 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0
Fungal infection  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1
Infection  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Lung infection  1  1/4 (25.00%)  1 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Nasopharyngitis  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 1/10 (10.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0
Oral candidiasis  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0
Paronychia  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 2/6 (33.33%)  2
Urinary tract infection  1  0/4 (0.00%)  0 0/13 (0.00%)  0 1/3 (33.33%)  1 1/8 (12.50%)  1 1/10 (10.00%)  1 0/3 (0.00%)  0 2/6 (33.33%)  3
Viral upper respiratory tract infection  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 2/8 (25.00%)  2 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Injury, poisoning and procedural complications               
Chemical eye injury  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1
Contusion  1  0/4 (0.00%)  0 0/13 (0.00%)  0 2/3 (66.67%)  2 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Fall  1  0/4 (0.00%)  0 1/13 (7.69%)  1 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Infusion related reaction  1  1/4 (25.00%)  1 1/13 (7.69%)  1 0/3 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 0/3 (0.00%)  0 2/6 (33.33%)  2
Post procedural haemorrhage  1  1/4 (25.00%)  1 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1
Investigations               
Alanine aminotransferase increased  1  0/4 (0.00%)  0 5/13 (38.46%)  5 0/3 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  2 1/3 (33.33%)  1 3/6 (50.00%)  7
Aspartate aminotransferase increased  1  1/4 (25.00%)  1 5/13 (38.46%)  5 0/3 (0.00%)  0 1/8 (12.50%)  1 1/10 (10.00%)  1 1/3 (33.33%)  1 2/6 (33.33%)  5
Blood albumin decreased  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1
Blood alkaline phosphatase increased  1  0/4 (0.00%)  0 3/13 (23.08%)  3 0/3 (0.00%)  0 1/8 (12.50%)  1 0/10 (0.00%)  0 0/3 (0.00%)  0 3/6 (50.00%)  5
Blood bilirubin increased  1  0/4 (0.00%)  0 1/13 (7.69%)  1 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 1/3 (33.33%)  1 1/6 (16.67%)  3
Blood cholesterol increased  1  0/4 (0.00%)  0 1/13 (7.69%)  1 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Blood creatinine increased  1  0/4 (0.00%)  0 0/13 (0.00%)  0 1/3 (33.33%)  1 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  3
Blood lactate dehydrogenase increased  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1
Blood triglycerides increased  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1
Blood urea increased  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 0/10 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1
Breath sounds abnormal  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0
Gamma-glutamyltransferase increased  1  0/4 (0.00%)  0 3/13 (23.08%)  3 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Haemoglobin decreased  1  1/4 (25.00%)  1 1/13 (7.69%)  1 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
International normalised ratio increased  1  1/4 (25.00%)  1 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Lymphocyte count decreased  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 2/10 (20.00%)  2 0/3 (0.00%)  0 0/6 (0.00%)  0
Weight decreased  1  1/4 (25.00%)  1 4/13 (30.77%)  4 0/3 (0.00%)  0 5/8 (62.50%)  5 1/10 (10.00%)  1 1/3 (33.33%)  1 3/6 (50.00%)  3
White blood cell count decreased  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 0/3 (0.00%)  0 1/6 (16.67%)  1
Metabolism and nutrition disorders               
Decreased appetite  1  3/4 (75.00%)  3 8/13 (61.54%)  9 0/3 (0.00%)  0 5/8 (62.50%)  6 4/10 (40.00%)  4 3/3 (100.00%)  5 3/6 (50.00%)  4
Dehydration  1  0/4 (0.00%)  0 4/13 (30.77%)  4 0/3 (0.00%)  0 1/8 (12.50%)  1 0/10 (0.00%)  0 1/3 (33.33%)  1 2/6 (33.33%)  2
Hypercalcaemia  1  0/4 (0.00%)  0 1/13 (7.69%)  1 0/3 (0.00%)  0 1/8 (12.50%)  2 0/10 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1
Hypercholesterolaemia  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1
Hyperglycaemia  1  0/4 (0.00%)  0 2/13 (15.38%)  2 1/3 (33.33%)  1 3/8 (37.50%)  3 5/10 (50.00%)  7 1/3 (33.33%)  2 5/6 (83.33%)  9
Hypernatraemia  1  0/4 (0.00%)  0 1/13 (7.69%)  1 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Hypertriglyceridaemia  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 0/3 (0.00%)  0 2/6 (33.33%)  4
Hypoalbuminaemia  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 3/6 (50.00%)  4
Hypocalcaemia  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1
Hypoglycaemia  1  0/4 (0.00%)  0 1/13 (7.69%)  1 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Hypokalaemia  1  0/4 (0.00%)  0 2/13 (15.38%)  2 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 3/6 (50.00%)  5
Hypomagnesaemia  1  0/4 (0.00%)  0 2/13 (15.38%)  2 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 1/3 (33.33%)  2 1/6 (16.67%)  5
Hyponatraemia  1  0/4 (0.00%)  0 1/13 (7.69%)  1 0/3 (0.00%)  0 2/8 (25.00%)  2 0/10 (0.00%)  0 1/3 (33.33%)  1 1/6 (16.67%)  1
Hypophosphataemia  1  1/4 (25.00%)  1 2/13 (15.38%)  2 0/3 (0.00%)  0 1/8 (12.50%)  1 0/10 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  2
Musculoskeletal and connective tissue disorders               
Arthralgia  1  3/4 (75.00%)  5 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 1/3 (33.33%)  1 0/6 (0.00%)  0
Arthritis  1  0/4 (0.00%)  0 1/13 (7.69%)  1 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Back pain  1  2/4 (50.00%)  2 1/13 (7.69%)  1 0/3 (0.00%)  0 1/8 (12.50%)  1 2/10 (20.00%)  2 1/3 (33.33%)  1 2/6 (33.33%)  2
Bone pain  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0
Flank pain  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 2/10 (20.00%)  2 0/3 (0.00%)  0 1/6 (16.67%)  1
Groin pain  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Muscle spasms  1  0/4 (0.00%)  0 2/13 (15.38%)  2 1/3 (33.33%)  1 3/8 (37.50%)  3 5/10 (50.00%)  6 0/3 (0.00%)  0 1/6 (16.67%)  1
Muscle swelling  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Muscular weakness  1  1/4 (25.00%)  1 1/13 (7.69%)  1 0/3 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 0/3 (0.00%)  0 1/6 (16.67%)  1
Musculoskeletal stiffness  1  0/4 (0.00%)  0 1/13 (7.69%)  1 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Myalgia  1  1/4 (25.00%)  2 1/13 (7.69%)  1 0/3 (0.00%)  0 1/8 (12.50%)  3 0/10 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0
Neck pain  1  1/4 (25.00%)  1 1/13 (7.69%)  1 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Pain in extremity  1  2/4 (50.00%)  4 3/13 (23.08%)  3 0/3 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 0/3 (0.00%)  0 1/6 (16.67%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)               
Metastases to abdominal wall  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1
Tumour pain  1  0/4 (0.00%)  0 0/13 (0.00%)  0 1/3 (33.33%)  1 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Nervous system disorders               
Ageusia  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0
Cognitive disorder  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0
Dizziness  1  1/4 (25.00%)  1 0/13 (0.00%)  0 0/3 (0.00%)  0 3/8 (37.50%)  5 1/10 (10.00%)  1 1/3 (33.33%)  1 0/6 (0.00%)  0
Dysgeusia  1  0/4 (0.00%)  0 1/13 (7.69%)  1 0/3 (0.00%)  0 1/8 (12.50%)  1 3/10 (30.00%)  3 0/3 (0.00%)  0 2/6 (33.33%)  2
Headache  1  0/4 (0.00%)  0 3/13 (23.08%)  4 1/3 (33.33%)  1 3/8 (37.50%)  5 3/10 (30.00%)  3 0/3 (0.00%)  0 1/6 (16.67%)  2
Hyperaesthesia  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Hypersomnia  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Memory impairment  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1
Migraine  1  0/4 (0.00%)  0 1/13 (7.69%)  1 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Neuropathy peripheral  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 1/10 (10.00%)  1 1/3 (33.33%)  1 0/6 (0.00%)  0
Paraesthesia  1  1/4 (25.00%)  1 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Parosmia  1  0/4 (0.00%)  0 1/13 (7.69%)  1 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Somnolence  1  1/4 (25.00%)  1 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0
Transient ischaemic attack  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0
Tremor  1  1/4 (25.00%)  1 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Psychiatric disorders               
Anxiety  1  1/4 (25.00%)  1 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Confusional state  1  0/4 (0.00%)  0 1/13 (7.69%)  1 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0
Depression  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1
Disorientation  1  0/4 (0.00%)  0 1/13 (7.69%)  1 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Insomnia  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 1/10 (10.00%)  1 0/3 (0.00%)  0 1/6 (16.67%)  1
Nightmare  1  0/4 (0.00%)  0 1/13 (7.69%)  1 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Personality change  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0
Renal and urinary disorders               
Chromaturia  1  0/4 (0.00%)  0 1/13 (7.69%)  1 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Dysuria  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Hydronephrosis  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1
Micturition urgency  1  0/4 (0.00%)  0 1/13 (7.69%)  1 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0
Nephrolithiasis  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1
Pollakiuria  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0
Proteinuria  1  0/4 (0.00%)  0 1/13 (7.69%)  1 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1
Reproductive system and breast disorders               
Breast pain  1  0/4 (0.00%)  0 1/13 (7.69%)  1 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Vaginal discharge  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1
Respiratory, thoracic and mediastinal disorders               
Atelectasis  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 2/6 (33.33%)  2
Cough  1  0/4 (0.00%)  0 4/13 (30.77%)  5 0/3 (0.00%)  0 1/8 (12.50%)  1 0/10 (0.00%)  0 1/3 (33.33%)  1 2/6 (33.33%)  3
Dysphonia  1  1/4 (25.00%)  1 1/13 (7.69%)  1 0/3 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0
Dyspnoea  1  1/4 (25.00%)  1 2/13 (15.38%)  2 0/3 (0.00%)  0 1/8 (12.50%)  1 2/10 (20.00%)  2 1/3 (33.33%)  1 2/6 (33.33%)  2
Epistaxis  1  0/4 (0.00%)  0 1/13 (7.69%)  1 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 3/6 (50.00%)  6
Haemoptysis  1  0/4 (0.00%)  0 1/13 (7.69%)  1 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Hypoxia  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1
Increased upper airway secretion  1  0/4 (0.00%)  0 1/13 (7.69%)  2 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Laryngeal haemorrhage  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Nasal congestion  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Nasal dryness  1  0/4 (0.00%)  0 0/13 (0.00%)  0 1/3 (33.33%)  1 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Oropharyngeal pain  1  2/4 (50.00%)  2 2/13 (15.38%)  2 0/3 (0.00%)  0 2/8 (25.00%)  2 2/10 (20.00%)  2 0/3 (0.00%)  0 0/6 (0.00%)  0
Pleural effusion  1  0/4 (0.00%)  0 2/13 (15.38%)  2 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Pneumonitis  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1
Productive cough  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 0/10 (0.00%)  0 0/3 (0.00%)  0 2/6 (33.33%)  3
Pulmonary embolism  1  1/4 (25.00%)  1 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Rhinitis allergic  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 2/8 (25.00%)  2 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Rhinorrhoea  1  0/4 (0.00%)  0 1/13 (7.69%)  1 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Sinus congestion  1  0/4 (0.00%)  0 1/13 (7.69%)  1 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Sneezing  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0
Tachypnoea  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0
Skin and subcutaneous tissue disorders               
Acne  1  0/4 (0.00%)  0 1/13 (7.69%)  1 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Dermatitis contact  1  0/4 (0.00%)  0 0/13 (0.00%)  0 1/3 (33.33%)  1 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1
Dry skin  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 3/8 (37.50%)  3 5/10 (50.00%)  5 0/3 (0.00%)  0 1/6 (16.67%)  1
Erythema  1  1/4 (25.00%)  1 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 2/10 (20.00%)  2 1/3 (33.33%)  1 0/6 (0.00%)  0
Hyperhidrosis  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 1/3 (33.33%)  2 0/6 (0.00%)  0
Nail discolouration  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Nail disorder  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 1/10 (10.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0
Pain of skin  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Petechiae  1  1/4 (25.00%)  1 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1
Pruritus  1  0/4 (0.00%)  0 1/13 (7.69%)  1 1/3 (33.33%)  1 0/8 (0.00%)  0 3/10 (30.00%)  4 0/3 (0.00%)  0 0/6 (0.00%)  0
Purpura  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0
Rash  1  0/4 (0.00%)  0 1/13 (7.69%)  1 2/3 (66.67%)  2 4/8 (50.00%)  9 2/10 (20.00%)  2 0/3 (0.00%)  0 0/6 (0.00%)  0
Rash generalised  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0
Rash maculo-papular  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 4/10 (40.00%)  5 2/3 (66.67%)  2 0/6 (0.00%)  0
Rash pruritic  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1
Scab  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0
Skin discolouration  1  0/4 (0.00%)  0 1/13 (7.69%)  1 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Skin fissures  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0
Skin irritation  1  0/4 (0.00%)  0 0/13 (0.00%)  0 1/3 (33.33%)  1 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Vascular disorders               
Deep vein thrombosis  1  1/4 (25.00%)  1 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Haematoma  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 1/3 (33.33%)  1 1/6 (16.67%)  1
Hot flush  1  0/4 (0.00%)  0 0/13 (0.00%)  0 1/3 (33.33%)  1 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Hypertension  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 3/10 (30.00%)  3 0/3 (0.00%)  0 0/6 (0.00%)  0
Hypotension  1  0/4 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 0/10 (0.00%)  0 1/3 (33.33%)  2 0/6 (0.00%)  0
Vasculitis  1  1/4 (25.00%)  1 0/13 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
The study was terminated for business reasons and not due to any safety or efficacy concerns related to dalotuzumab.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The sponsor must review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation and can delete information identified as confidential prior to submission.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01243762     History of Changes
Other Study ID Numbers: 0646-027
First Submitted: November 17, 2010
First Posted: November 19, 2010
Results First Submitted: June 13, 2017
Results First Posted: October 30, 2017
Last Update Posted: August 16, 2018