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Trial record 10 of 118 for:    oseltamivir

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics (PK) of Oseltamivir and Its Carboxylate Metabolite, RO0640802 in Healthy Participants

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ClinicalTrials.gov Identifier: NCT02717754
Recruitment Status : Completed
First Posted : March 24, 2016
Results First Posted : June 27, 2016
Last Update Posted : June 27, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator)
Condition Healthy Volunteer
Interventions Drug: Oseltamivir
Drug: Placebo
Enrollment 99
Recruitment Details In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).
Pre-assignment Details  
Arm/Group Title Placebo Oseltamivir 100 mg Oseltamivir 200 mg Placebo (Incorrect Infusion Duration) Oseltamivir 100 mg (Incorrect Infusion Duration) Oseltamivir 200 mg (Incorrect Infusion Duration)
Hide Arm/Group Description Participants received oseltamivir matched placebo twice daily (BID) for 5 days. Participants received 100 milligrams (mg) oseltamivir intravenous BID for 5 days. Participants received 200 mg oseltamivir intravenous BID for 5 days. Participants were randomized to receive oseltamivir matched placebo intravenous BID for 5 days but received incorrect infusion duration. Participants were randomized to receive oseltamivir 100 mg intravenous BID for 5 days but received incorrect infusion duration. Participants were randomized to receive oseltamivir 200 mg intravenous BID for 5 days but received incorrect infusion duration.
Period Title: Overall Study
Started 10 19 20 10 20 20
Completed 10 19 20 0 0 0
Not Completed 0 0 0 10 20 20
Reason Not Completed
Incorrect Infusion Duration             0             0             0             10             20             20
Arm/Group Title Placebo Oseltamivir 100 mg Oseltamivir 200 mg Placebo (Incorrect Infusion Duration) Oseltamivir 100 mg (Incorrect Infusion Duration) Oseltamivir 200 mg (Incorrect Infusion Duration) Total
Hide Arm/Group Description Participants received oseltamivir matched placebo BID for 5 days. Participants received 100 mg oseltamivir intravenous BID for 5 days. Participants received 200 mg oseltamivir intravenous BID for 5 days. Participants were randomized to receive oseltamivir matched placebo intravenous BID for 5 days but received incorrect infusion duration. Participants were randomized to receive oseltamivir 100 mg intravenous BID for 5 days but received incorrect infusion duration. Participants were randomized to receive oseltamivir 200 mg intravenous BID for 5 days but received incorrect infusion duration. Total of all reporting groups
Overall Number of Baseline Participants 10 19 20 10 20 20 99
Hide Baseline Analysis Population Description
Safety population included all participants who received at least one dose of study drug and have a safety assessment performed after initiation of treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 19 participants 20 participants 10 participants 20 participants 20 participants 99 participants
28.1  (6.19) 28.3  (6.97) 30.2  (7.73) 29.7  (7.90) 31.1  (7.80) 28.6  (8.09) 29.4040  (7.44904)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 19 participants 20 participants 10 participants 20 participants 20 participants 99 participants
Female
5
  50.0%
10
  52.6%
4
  20.0%
1
  10.0%
3
  15.0%
4
  20.0%
27
  27.3%
Male
5
  50.0%
9
  47.4%
16
  80.0%
9
  90.0%
17
  85.0%
16
  80.0%
72
  72.7%
1.Primary Outcome
Title Area Under the Plasma Concentration-Time Curve From Time 0 to 12 Hour (AUC0-12h) of Oseltamivir and RO0640802 at Steady State
Hide Description AUC is a measure of the plasma concentration of the drug over time. AUC is presented in nanogram times (*) hour per milliliter (ng*hour/mL). RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.
Time Frame Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analysis population included all participants who were dosed correctly. Only participants who received oseltamivir were analyzed.
Arm/Group Title Oseltamivir 100 mg Oseltamivir 200 mg
Hide Arm/Group Description:
Participants received 100 mg oseltamivir intravenous BID for 5 days.
Participants received 200 mg oseltamivir intravenous BID for 5 days.
Overall Number of Participants Analyzed 19 20
Mean (Standard Deviation)
Unit of Measure: ng*hour/mL
Oseltamivir 581  (178) 1143  (178)
RO0640802 4147  (742) 7966  (1427)
2.Primary Outcome
Title Maximum Plasma Concentration (Cmax) of Oseltamivir and RO0640802 at Steady State
Hide Description Cmax is the maximum observed plasma concentration, presented in nanogram per milliliter (ng/mL). RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.
Time Frame Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis population. Only participants who received oseltamivir were analyzed.
Arm/Group Title Oseltamivir 100 mg Oseltamivir 200 mg
Hide Arm/Group Description:
Participants received 100 mg oseltamivir intravenous BID for 5 days.
Participants received 200 mg oseltamivir intravenous BID for 5 days.
Overall Number of Participants Analyzed 19 20
Mean (Standard Deviation)
Unit of Measure: ng/mL
Oseltamivir 266  (73.1) 496  (69.7)
RO0640802 488  (84.1) 960  (178)
3.Secondary Outcome
Title Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Oseltamivir and RO0640802
Hide Description AUC is a measure of the plasma concentration of the drug over time. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.
Time Frame Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis population. Only participants who received oseltamivir were analyzed.
Arm/Group Title Oseltamivir 100 mg Oseltamivir 200 mg
Hide Arm/Group Description:
Participants received 100 mg oseltamivir intravenous BID for 5 days.
Participants received 200 mg oseltamivir intravenous BID for 5 days.
Overall Number of Participants Analyzed 19 20
Mean (Standard Deviation)
Unit of Measure: ng*hour/mL
Oseltamivir 612  (134) 1139  (220)
RO0640802 3606  (761) 7336  (1952)
4.Secondary Outcome
Title Area Under the Plasma Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUC0-last) of Oseltamivir and RO0640802
Hide Description AUC is a measure of the plasma concentration of the drug over time. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.
Time Frame Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 and Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis population. Only participants who received oseltamivir were analyzed.
Arm/Group Title Oseltamivir 100 mg Oseltamivir 200 mg
Hide Arm/Group Description:
Participants received 100 mg oseltamivir intravenous BID for 5 days.
Participants received 200 mg oseltamivir intravenous BID for 5 days.
Overall Number of Participants Analyzed 19 20
Mean (Standard Deviation)
Unit of Measure: ng*hour/mL
Day 1: Oseltamivir 609  (134) 1136  (220)
Day 1: RO0640802 2273  (405) 4566  (714)
Day 5: Oseltamivir 580  (178) 1142  (178)
Day 5: RO0640802 4127  (738) 7932  (1417)
5.Secondary Outcome
Title Cmax of Oseltamivir and RO0640802
Hide Description Cmax is the maximum observed plasma concentration. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.
Time Frame Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis population. Only participants who received oseltamivir were analyzed.
Arm/Group Title Oseltamivir 100 mg Oseltamivir 200 mg
Hide Arm/Group Description:
Participants received 100 mg oseltamivir intravenous BID for 5 days.
Participants received 200 mg oseltamivir intravenous BID for 5 days.
Overall Number of Participants Analyzed 19 20
Mean (Standard Deviation)
Unit of Measure: ng/mL
Oseltamivir 284  (54.3) 503  (93.1)
RO0640802 301  (69.8) 577  (88.9)
6.Secondary Outcome
Title Time to Reach Maximum Plasma Concentration (Tmax) of Oseltamivir and RO0640802
Hide Description Tmax is time of observed maximum plasma concentration. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.
Time Frame Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 and Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis population. Only participants who received oseltamivir were analyzed.
Arm/Group Title Oseltamivir 100 mg Oseltamivir 200 mg
Hide Arm/Group Description:
Participants received 100 mg oseltamivir intravenous BID for 5 days.
Participants received 200 mg oseltamivir intravenous BID for 5 days.
Overall Number of Participants Analyzed 19 20
Mean (Standard Deviation)
Unit of Measure: hour
Day 1: Oseltamivir 1.85  (0.377) 1.65  (0.491)
Day 1: RO0640802 3.90  (0.91) 3.95  (1.28)
Day 5: Oseltamivir 1.64  (0.492) 1.81  (0.416)
Day 5: RO0640802 3.69  (0.917) 3.41  (0.851)
7.Secondary Outcome
Title Half-Life (t1/2) of Oseltamivir and RO0640802
Hide Description t1/2 is the time measured for the plasma concentration to decrease by one half. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.
Time Frame Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 and Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis population. Only participants who received oseltamivir were analyzed.
Arm/Group Title Oseltamivir 100 mg Oseltamivir 200 mg
Hide Arm/Group Description:
Participants received 100 mg oseltamivir intravenous BID for 5 days.
Participants received 200 mg oseltamivir intravenous BID for 5 days.
Overall Number of Participants Analyzed 19 20
Mean (Standard Deviation)
Unit of Measure: hour
Day 1: Oseltamivir 1.22  (0.32) 1.53  (0.293)
Day 1: RO0640802 6.89  (2.08) 7.17  (2.19)
Day 5: Oseltamivir 1.40  (0.327) 1.88  (0.457)
Day 5: RO0640802 7.97  (1.82) 8.17  (2.23)
8.Secondary Outcome
Title Volume of Distribution (Vd) of Oseltamivir and RO0640802
Hide Description Vd is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.
Time Frame Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 and Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis population. Only participants who received oseltamivir were analyzed.
Arm/Group Title Oseltamivir 100 mg Oseltamivir 200 mg
Hide Arm/Group Description:
Participants received 100 mg oseltamivir intravenous BID for 5 days.
Participants received 200 mg oseltamivir intravenous BID for 5 days.
Overall Number of Participants Analyzed 19 20
Mean (Standard Deviation)
Unit of Measure: Liter
Day 1: Oseltamivir 171  (36.4) 183  (39)
Day 1: RO0640802 250  (55) 251  (45.7)
Day 5: Oseltamivir 189  (103) 192  (31.0)
Day 5: RO0640802 266  (58.9) 280  (65.9)
9.Secondary Outcome
Title Clearance (CL) of Oseltamivir and RO0640802
Hide Description CL is a quantitative measure of the rate at which a drug substance is removed from the body. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.
Time Frame Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 and Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis population. Only participants who received oseltamivir were analyzed.
Arm/Group Title Oseltamivir 100 mg Oseltamivir 200 mg
Hide Arm/Group Description:
Participants received 100 mg oseltamivir intravenous BID for 5 days.
Participants received 200 mg oseltamivir intravenous BID for 5 days.
Overall Number of Participants Analyzed 19 20
Mean (Standard Deviation)
Unit of Measure: Liters/hour
Day 1: Oseltamivir 289  (55) 393  (67)
Day 1: RO0640802 26.0  (5.4) 25.4  (6.1)
Day 5: Oseltamivir 192  (74.6) 179  (30.3)
Day 5: RO0640802 21.7  (3.80) 22.6  (3.9)
10.Secondary Outcome
Title Minimum Plasma Concentration (Cmin) of RO0640802
Hide Description Collection of the 12-hour post-dose sample took place prior to administration of the second daily dose of drug. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.
Time Frame 12-hour post dose on Day 1, 5 and predose on Day 2, 3, 4, 5
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis population. Only participants who received oseltamivir were analyzed.
Arm/Group Title Oseltamivir 100 mg Oseltamivir 200 mg
Hide Arm/Group Description:
Participants received 100 mg oseltamivir intravenous BID for 5 days.
Participants received 200 mg oseltamivir intravenous BID for 5 days.
Overall Number of Participants Analyzed 19 20
Mean (Standard Deviation)
Unit of Measure: ng/mL
Day 1 (12-hour post dose) 131  (29.3) 264  (59.1)
Day 2 (Pre dose) 209  (43.6) 388  (95.4)
Day 3 (Pre dose) 235  (56.3) 450  (101)
Day 4 (Pre dose) 277  (104) 443  (143)
Day 5 (Pre dose) 262  (68.4) 502  (130.4)
Day 5 (12-hour post dose) 238  (61.8) 458  (110)
Time Frame Up to 10 days after last dose of study drug (32 days)
Adverse Event Reporting Description In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).
 
Arm/Group Title Placebo Oseltamivir 100 mg Oseltamivir 200 mg Placebo (Incorrect Infusion Duration) Oseltamivir 100 mg (Incorrect Infusion Duration) Oseltamivir 200 mg (Incorrect Infusion Duration)
Hide Arm/Group Description Participants received oseltamivir matched placebo for 5 days. Participants received 100 mg oseltamivir intravenous BID for 5 days. Participants received 200 mg oseltamivir intravenous BID for 5 days. Participants were randomized to receive oseltamivir matched placebo intravenous BID for 5 days but received incorrect infusion duration. Participants were randomized to receive oseltamivir 100 mg intravenous BID for 5 days but received incorrect infusion duration. Participants were randomized to receive oseltamivir 200 mg intravenous BID for 5 days but received incorrect infusion duration.
All-Cause Mortality
Placebo Oseltamivir 100 mg Oseltamivir 200 mg Placebo (Incorrect Infusion Duration) Oseltamivir 100 mg (Incorrect Infusion Duration) Oseltamivir 200 mg (Incorrect Infusion Duration)
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
Placebo Oseltamivir 100 mg Oseltamivir 200 mg Placebo (Incorrect Infusion Duration) Oseltamivir 100 mg (Incorrect Infusion Duration) Oseltamivir 200 mg (Incorrect Infusion Duration)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/19 (0.00%)   0/20 (0.00%)   0/10 (0.00%)   0/20 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Oseltamivir 100 mg Oseltamivir 200 mg Placebo (Incorrect Infusion Duration) Oseltamivir 100 mg (Incorrect Infusion Duration) Oseltamivir 200 mg (Incorrect Infusion Duration)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/10 (70.00%)   17/19 (89.47%)   20/20 (100.00%)   2/10 (20.00%)   8/20 (40.00%)   13/20 (65.00%) 
Ear and labyrinth disorders             
Tinnitus * 1  0/10 (0.00%)  1/19 (5.26%)  0/20 (0.00%)  0/10 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Eye disorders             
Visual impairment * 1  0/10 (0.00%)  1/19 (5.26%)  0/20 (0.00%)  0/10 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Gastrointestinal disorders             
Abdominal pain * 1  0/10 (0.00%)  0/19 (0.00%)  1/20 (5.00%)  0/10 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Constipation * 1  0/10 (0.00%)  1/19 (5.26%)  0/20 (0.00%)  0/10 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Diarrhoea * 1  0/10 (0.00%)  0/19 (0.00%)  1/20 (5.00%)  0/10 (0.00%)  1/20 (5.00%)  0/20 (0.00%) 
Nausea * 1  1/10 (10.00%)  0/19 (0.00%)  0/20 (0.00%)  0/10 (0.00%)  2/20 (10.00%)  1/20 (5.00%) 
General disorders             
Infusion site pain * 1  3/10 (30.00%)  15/19 (78.95%)  15/20 (75.00%)  0/10 (0.00%)  0/20 (0.00%)  1/20 (5.00%) 
Infusion site erythema * 1  1/10 (10.00%)  6/19 (31.58%)  10/20 (50.00%)  0/10 (0.00%)  1/20 (5.00%)  4/20 (20.00%) 
Infusion site swelling * 1  3/10 (30.00%)  3/19 (15.79%)  1/20 (5.00%)  0/10 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Infusion site induration * 1  0/10 (0.00%)  4/19 (21.05%)  2/20 (10.00%)  0/10 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Vessel puncture site pain * 1  0/10 (0.00%)  2/19 (10.53%)  2/20 (10.00%)  0/10 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Catheter site pain * 1  1/10 (10.00%)  1/19 (5.26%)  0/20 (0.00%)  0/10 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Infusion site anaesthesia * 1  1/10 (10.00%)  0/19 (0.00%)  1/20 (5.00%)  0/10 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Catheter site swelling * 1  1/10 (10.00%)  0/19 (0.00%)  0/20 (0.00%)  0/10 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Feeling hot * 1  0/10 (0.00%)  1/19 (5.26%)  0/20 (0.00%)  0/10 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Infusion site coldness * 1  1/10 (10.00%)  0/19 (0.00%)  0/20 (0.00%)  0/10 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Infusion site extravasation * 1  0/10 (0.00%)  1/19 (5.26%)  0/20 (0.00%)  0/10 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Infusion site warmth * 1  0/10 (0.00%)  0/19 (0.00%)  1/20 (5.00%)  0/10 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Vessel puncture site reaction * 1  0/10 (0.00%)  0/19 (0.00%)  1/20 (5.00%)  0/10 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Injection site pain * 1  0/10 (0.00%)  0/19 (0.00%)  0/20 (0.00%)  0/10 (0.00%)  2/20 (10.00%)  9/20 (45.00%) 
Injection site swelling * 1  0/10 (0.00%)  0/19 (0.00%)  0/20 (0.00%)  0/10 (0.00%)  1/20 (5.00%)  6/20 (30.00%) 
Injection site erythema * 1  0/10 (0.00%)  0/19 (0.00%)  0/20 (0.00%)  0/10 (0.00%)  2/20 (10.00%)  2/20 (10.00%) 
Injection site oedema * 1  0/10 (0.00%)  0/19 (0.00%)  0/20 (0.00%)  0/10 (0.00%)  1/20 (5.00%)  0/20 (0.00%) 
Oedema peripheral * 1  0/10 (0.00%)  0/19 (0.00%)  0/20 (0.00%)  0/10 (0.00%)  1/20 (5.00%)  0/20 (0.00%) 
Infections and infestations             
Nasopharyngitis * 1  0/10 (0.00%)  0/19 (0.00%)  1/20 (5.00%)  0/10 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Injury, poisoning and procedural complications             
Contusion * 1  0/10 (0.00%)  0/19 (0.00%)  0/20 (0.00%)  0/10 (0.00%)  1/20 (5.00%)  1/20 (5.00%) 
Musculoskeletal and connective tissue disorders             
Musculoskeletal chest pain * 1  0/10 (0.00%)  0/19 (0.00%)  1/20 (5.00%)  0/10 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Musculoskeletal discomfort * 1  0/10 (0.00%)  0/19 (0.00%)  1/20 (5.00%)  0/10 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Musculoskeletal pain * 1  0/10 (0.00%)  0/19 (0.00%)  1/20 (5.00%)  0/10 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Nervous system disorders             
Dizziness * 1  1/10 (10.00%)  2/19 (10.53%)  1/20 (5.00%)  1/10 (10.00%)  0/20 (0.00%)  0/20 (0.00%) 
Headache * 1  0/10 (0.00%)  1/19 (5.26%)  2/20 (10.00%)  0/10 (0.00%)  1/20 (5.00%)  0/20 (0.00%) 
Paraesthesia * 1  0/10 (0.00%)  0/19 (0.00%)  1/20 (5.00%)  0/10 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Sneezing * 1  1/10 (10.00%)  0/19 (0.00%)  0/20 (0.00%)  0/10 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Oropharyngeal pain * 1  0/10 (0.00%)  0/19 (0.00%)  0/20 (0.00%)  1/10 (10.00%)  0/20 (0.00%)  0/20 (0.00%) 
Skin and subcutaneous tissue disorders             
Pruritus * 1  1/10 (10.00%)  0/19 (0.00%)  2/20 (10.00%)  0/10 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Dry skin * 1  0/10 (0.00%)  0/19 (0.00%)  1/20 (5.00%)  0/10 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Ecchymosis * 1  0/10 (0.00%)  1/19 (5.26%)  0/20 (0.00%)  0/10 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Seborrhoeic dermatitis * 1  0/10 (0.00%)  1/19 (5.26%)  0/20 (0.00%)  0/10 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Hyperhidrosis * 1  0/10 (0.00%)  0/19 (0.00%)  0/20 (0.00%)  0/10 (0.00%)  1/20 (5.00%)  0/20 (0.00%) 
Rash * 1  0/10 (0.00%)  0/19 (0.00%)  0/20 (0.00%)  0/10 (0.00%)  0/20 (0.00%)  1/20 (5.00%) 
Vascular disorders             
Vein disorders * 1  1/10 (10.00%)  0/19 (0.00%)  0/20 (0.00%)  0/10 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (13.0)
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 Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-LaRoche
Phone: 800-821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02717754     History of Changes
Other Study ID Numbers: NP25140
First Submitted: March 20, 2016
First Posted: March 24, 2016
Results First Submitted: May 18, 2016
Results First Posted: June 27, 2016
Last Update Posted: June 27, 2016