Time Frame |
Serious adverse events (SAEs) and adverse events were collected from the first dose of randomized therapy until 30 days after the last dose of randomized therapy (average of 26 weeks).
|
Adverse Event Reporting Description |
SAEs and AEs were collected in the Safety Population, comprised of all randomized participants who received at least one dose of investigational product (based on the actual treatment received if this differed from that to which the participant was randomized). Two participants randomized to the placebo group actually received lapatinib.
|
|
Arm/Group Title
|
Lapatinib With Paclitaxel
|
Placebo With Paclitaxel
|
Arm/Group Description |
Participants received lapatinib 150...
|
Participants received matching plac...
|
Arm/Group Description |
Participants received lapatinib 1500 milligrams (mg) orally once daily (OD) with paclitaxel 175 mg/meters squared (m^2) intravenously (IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
|
Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
|
|
|
Lapatinib With Paclitaxel
|
Placebo With Paclitaxel
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
--/-- |
--/-- |
|
|
Lapatinib With Paclitaxel
|
Placebo With Paclitaxel
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
103/293 (35.15%) |
63/286 (22.03%) |
Blood and lymphatic system disorders |
|
|
Neutropenia |
22/293 (7.51%) |
14/286 (4.90%) |
Febrile neutropenia |
10/293 (3.41%) |
3/286 (1.05%) |
Disseminated intravascular coagulation |
0/293 (0.00%) |
1/286 (0.35%) |
Leukopenia |
0/293 (0.00%) |
1/286 (0.35%) |
Thrombocythemia |
1/293 (0.34%) |
0/286 (0.00%) |
Cardiac disorders |
|
|
Left ventricular dysfunction |
2/293 (0.68%) |
1/286 (0.35%) |
Atrial fibrillation |
1/293 (0.34%) |
0/286 (0.00%) |
Cardiac arrest |
1/293 (0.34%) |
0/286 (0.00%) |
Cardiac failure |
1/293 (0.34%) |
0/286 (0.00%) |
Myocardial infarction |
0/293 (0.00%) |
1/286 (0.35%) |
Ventricular arrhythmia |
1/293 (0.34%) |
0/286 (0.00%) |
Eye disorders |
|
|
Retinal detachment |
1/293 (0.34%) |
1/286 (0.35%) |
Ulcerative keratitis |
1/293 (0.34%) |
0/286 (0.00%) |
Pterygium |
1/293 (0.34%) |
0/286 (0.00%) |
Gastrointestinal disorders |
|
|
Diarrhea |
24/293 (8.19%) |
2/286 (0.70%) |
Vomiting |
4/293 (1.37%) |
4/286 (1.40%) |
Abdominal pain |
2/293 (0.68%) |
0/286 (0.00%) |
Nausea |
1/293 (0.34%) |
1/286 (0.35%) |
Ascites |
1/293 (0.34%) |
0/286 (0.00%) |
Constipation |
0/293 (0.00%) |
1/286 (0.35%) |
Gastrointestinal toxicity |
1/293 (0.34%) |
0/286 (0.00%) |
Ileus |
1/293 (0.34%) |
0/286 (0.00%) |
Intestinal ischemia |
1/293 (0.34%) |
0/286 (0.00%) |
Esophagitis |
1/293 (0.34%) |
0/286 (0.00%) |
Rectal hemorrhage |
0/293 (0.00%) |
1/286 (0.35%) |
Stomatitis |
1/293 (0.34%) |
0/286 (0.00%) |
General disorders |
|
|
Pyrexia |
7/293 (2.39%) |
2/286 (0.70%) |
Mucosal inflammation |
6/293 (2.05%) |
1/286 (0.35%) |
Chest pain |
2/293 (0.68%) |
2/286 (0.70%) |
Asthenia |
1/293 (0.34%) |
0/286 (0.00%) |
Death |
0/293 (0.00%) |
1/286 (0.35%) |
Edema peripheral |
1/293 (0.34%) |
0/286 (0.00%) |
Performance status decreased |
1/293 (0.34%) |
0/286 (0.00%) |
Hepatobiliary disorders |
|
|
Cholecystitis |
1/293 (0.34%) |
0/286 (0.00%) |
Cholecystitis chronic |
0/293 (0.00%) |
1/286 (0.35%) |
Cholelithiasis |
1/293 (0.34%) |
0/286 (0.00%) |
Hepatotoxicity |
1/293 (0.34%) |
0/286 (0.00%) |
Jaundice cholestatic |
0/293 (0.00%) |
1/286 (0.35%) |
Immune system disorders |
|
|
Hypersensitivity |
2/293 (0.68%) |
1/286 (0.35%) |
Anaphylactic reaction |
1/293 (0.34%) |
0/286 (0.00%) |
Infections and infestations |
|
|
Pneumonia |
3/293 (1.02%) |
2/286 (0.70%) |
Device related infection |
2/293 (0.68%) |
1/286 (0.35%) |
Sepsis |
2/293 (0.68%) |
1/286 (0.35%) |
Septic shock |
2/293 (0.68%) |
0/286 (0.00%) |
Staphylococcal infection |
1/293 (0.34%) |
1/286 (0.35%) |
Urinary tract infection |
2/293 (0.68%) |
0/286 (0.00%) |
Acarodermatitis |
1/293 (0.34%) |
0/286 (0.00%) |
Breast abscess |
0/293 (0.00%) |
1/286 (0.35%) |
Bronchopneumonia |
0/293 (0.00%) |
1/286 (0.35%) |
Catheter site infection |
1/293 (0.34%) |
0/286 (0.00%) |
Cellulitis |
0/293 (0.00%) |
1/286 (0.35%) |
Enterocolitis infectious |
1/293 (0.34%) |
0/286 (0.00%) |
Gallbladder abscess |
1/293 (0.34%) |
0/286 (0.00%) |
Lower respiratory tract infection |
1/293 (0.34%) |
0/286 (0.00%) |
Lung infection |
0/293 (0.00%) |
1/286 (0.35%) |
Lymphangitis |
1/293 (0.34%) |
0/286 (0.00%) |
Oral candidiasis |
1/293 (0.34%) |
0/286 (0.00%) |
Pneumonia primary atypical |
1/293 (0.34%) |
0/286 (0.00%) |
Pyelonephritis |
0/293 (0.00%) |
1/286 (0.35%) |
Skin infection |
0/293 (0.00%) |
1/286 (0.35%) |
Urosepsis |
0/293 (0.00%) |
1/286 (0.35%) |
Injury, poisoning and procedural complications |
|
|
Ankle fracture |
0/293 (0.00%) |
1/286 (0.35%) |
Femur fracture |
1/293 (0.34%) |
0/286 (0.00%) |
Foot fracture |
1/293 (0.34%) |
0/286 (0.00%) |
Poisoning |
1/293 (0.34%) |
0/286 (0.00%) |
Investigations |
|
|
Ejection fraction decreased |
5/293 (1.71%) |
5/286 (1.75%) |
Hemoglobin decreased |
1/293 (0.34%) |
1/286 (0.35%) |
Alanine aminotransferase increased |
1/293 (0.34%) |
0/286 (0.00%) |
Blood creatinine increased |
0/293 (0.00%) |
1/286 (0.35%) |
Blood uric acid increased |
0/293 (0.00%) |
1/286 (0.35%) |
Body temperature increased |
1/293 (0.34%) |
0/286 (0.00%) |
Neutrophil count decreased |
1/293 (0.34%) |
0/286 (0.00%) |
Metabolism and nutrition disorders |
|
|
Hypercalcemia |
4/293 (1.37%) |
3/286 (1.05%) |
Dehydration |
4/293 (1.37%) |
0/286 (0.00%) |
Hypokalemia |
2/293 (0.68%) |
0/286 (0.00%) |
Fluid overload |
0/293 (0.00%) |
1/286 (0.35%) |
Hyperglycemia |
1/293 (0.34%) |
0/286 (0.00%) |
Hyperkalemia |
0/293 (0.00%) |
1/286 (0.35%) |
Hypernatremia |
0/293 (0.00%) |
1/286 (0.35%) |
Hyperuricemia |
1/293 (0.34%) |
0/286 (0.00%) |
Hypocalcemia |
1/293 (0.34%) |
0/286 (0.00%) |
Hypoglycemia |
1/293 (0.34%) |
0/286 (0.00%) |
Hypomagnesemia |
1/293 (0.34%) |
0/286 (0.00%) |
Hyponatremia |
1/293 (0.34%) |
0/286 (0.00%) |
Hypovolemia |
1/293 (0.34%) |
0/286 (0.00%) |
Tetany |
1/293 (0.34%) |
0/286 (0.00%) |
Musculoskeletal and connective tissue disorders |
|
|
Pain in extremity |
3/293 (1.02%) |
0/286 (0.00%) |
Arthralgia |
2/293 (0.68%) |
0/286 (0.00%) |
Pathological fracture |
1/293 (0.34%) |
1/286 (0.35%) |
Back pain |
1/293 (0.34%) |
0/286 (0.00%) |
Intervertebral disc disorder |
0/293 (0.00%) |
1/286 (0.35%) |
Joint effusion |
1/293 (0.34%) |
0/286 (0.00%) |
Muscular weakness |
1/293 (0.34%) |
0/286 (0.00%) |
Myalgia |
0/293 (0.00%) |
1/286 (0.35%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
Breast cancer |
0/293 (0.00%) |
1/286 (0.35%) |
Metastases to central nervous system |
1/293 (0.34%) |
0/286 (0.00%) |
Tumor hemorrhage |
1/293 (0.34%) |
0/286 (0.00%) |
Nervous system disorders |
|
|
Convulsion |
1/293 (0.34%) |
1/286 (0.35%) |
Cerebral infarction |
0/293 (0.00%) |
1/286 (0.35%) |
Cerebrovascular disorder |
1/293 (0.34%) |
0/286 (0.00%) |
Headache |
1/293 (0.34%) |
0/286 (0.00%) |
Hemiplegia |
0/293 (0.00%) |
1/286 (0.35%) |
Lumber radiculopathy |
0/293 (0.00%) |
1/286 (0.35%) |
Mental impairment |
1/293 (0.34%) |
0/286 (0.00%) |
Neuralgia |
1/293 (0.34%) |
0/286 (0.00%) |
Peripheral motor neuropathy |
0/293 (0.00%) |
1/286 (0.35%) |
Peripheral sensory neuropathy |
0/293 (0.00%) |
1/286 (0.35%) |
Somnolence |
1/293 (0.34%) |
0/286 (0.00%) |
Syncope |
1/293 (0.34%) |
0/286 (0.00%) |
Psychiatric disorders |
|
|
Anxiety |
0/293 (0.00%) |
1/286 (0.35%) |
Confusional state |
0/293 (0.00%) |
1/286 (0.35%) |
Mental status changes |
0/293 (0.00%) |
1/286 (0.35%) |
Renal and urinary disorders |
|
|
Renal colic |
1/293 (0.34%) |
0/286 (0.00%) |
Renal failure acute |
1/293 (0.34%) |
0/286 (0.00%) |
Urinary retention |
0/293 (0.00%) |
1/286 (0.35%) |
Respiratory, thoracic and mediastinal disorders |
|
|
Dyspnea |
3/293 (1.02%) |
3/286 (1.05%) |
Pulmonary embolism |
2/293 (0.68%) |
0/286 (0.00%) |
Cough |
1/293 (0.34%) |
0/286 (0.00%) |
Epistaxis |
1/293 (0.34%) |
0/286 (0.00%) |
Hemothorax |
0/293 (0.00%) |
1/286 (0.35%) |
Hypoxia |
0/293 (0.00%) |
1/286 (0.35%) |
Pleural effusion |
0/293 (0.00%) |
1/286 (0.35%) |
Pneumonitis |
0/293 (0.00%) |
1/286 (0.35%) |
Pulmonary hemorrhage |
1/293 (0.34%) |
0/286 (0.00%) |
Pulmonary edema |
1/293 (0.34%) |
0/286 (0.00%) |
Wheezing |
1/293 (0.34%) |
0/286 (0.00%) |
Skin and subcutaneous tissue disorders |
|
|
Rash |
4/293 (1.37%) |
0/286 (0.00%) |
Erythema multiforme |
1/293 (0.34%) |
0/286 (0.00%) |
Intertrigo |
0/293 (0.00%) |
1/286 (0.35%) |
Rash erythematous |
1/293 (0.34%) |
0/286 (0.00%) |
Rash generalized |
0/293 (0.00%) |
1/286 (0.35%) |
Vascular disorders |
|
|
Hypotension |
3/293 (1.02%) |
0/286 (0.00%) |
Thrombosis |
1/293 (0.34%) |
2/286 (0.70%) |
Deep vein thrombosis |
2/293 (0.68%) |
0/286 (0.00%) |
Hypertension |
0/293 (0.00%) |
2/286 (0.70%) |
Embolism |
1/293 (0.34%) |
0/286 (0.00%) |
Hemorrhage |
1/293 (0.34%) |
0/286 (0.00%) |
Hypertensive crisis |
1/293 (0.34%) |
0/286 (0.00%) |
Phlebitis |
0/293 (0.00%) |
1/286 (0.35%) |
Indicates events were collected by systematic assessment
Term from vocabulary, MedDRA
|
|
Frequency Threshold for Reporting Other Adverse Events
|
0%
|
|
Lapatinib With Paclitaxel
|
Placebo With Paclitaxel
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
287/293 (97.95%) |
278/286 (97.20%) |
Blood and lymphatic system disorders |
|
|
Neutropenia |
76/293 (25.94%) |
58/286 (20.28%) |
Anemia |
32/293 (10.92%) |
35/286 (12.24%) |
Leukopenia |
26/293 (8.87%) |
25/286 (8.74%) |
Febrile neutropenia |
12/293 (4.10%) |
4/286 (1.40%) |
Leukocytosis |
2/293 (0.68%) |
5/286 (1.75%) |
Thrombocytopenia |
2/293 (0.68%) |
4/286 (1.40%) |
Lymphopenia |
2/293 (0.68%) |
1/286 (0.35%) |
Lymph node pain |
1/293 (0.34%) |
1/286 (0.35%) |
Thrombocytosis |
1/293 (0.34%) |
1/286 (0.35%) |
Disseminated intravascular coagulation |
0/293 (0.00%) |
1/286 (0.35%) |
Eosinophilia |
1/293 (0.34%) |
0/286 (0.00%) |
Hyperchromasia |
1/293 (0.34%) |
0/286 (0.00%) |
Monocytosis |
1/293 (0.34%) |
0/286 (0.00%) |
Pancytopenia |
1/293 (0.34%) |
0/286 (0.00%) |
Ear and labyrinth disorders |
|
|
Vertigo |
4/293 (1.37%) |
7/286 (2.45%) |
Tinnitus |
2/293 (0.68%) |
1/286 (0.35%) |
Deafness |
1/293 (0.34%) |
0/286 (0.00%) |
Ear pain |
1/293 (0.34%) |
0/286 (0.00%) |
Hypoacusis |
0/293 (0.00%) |
1/286 (0.35%) |
Endocrine disorders |
|
|
Cushingoid |
1/293 (0.34%) |
0/286 (0.00%) |
Hypothyroidism |
0/293 (0.00%) |
1/286 (0.35%) |
Gastrointestinal disorders |
|
|
Diarrhea |
171/293 (58.36%) |
73/286 (25.52%) |
Nausea |
100/293 (34.13%) |
85/286 (29.72%) |
Vomiting |
74/293 (25.26%) |
48/286 (16.78%) |
Constipation |
35/293 (11.95%) |
48/286 (16.78%) |
Dyspepsia |
38/293 (12.97%) |
13/286 (4.55%) |
Abdominal pain |
33/293 (11.26%) |
17/286 (5.94%) |
Stomatitis |
21/293 (7.17%) |
13/286 (4.55%) |
Abdominal pain upper |
12/293 (4.10%) |
16/286 (5.59%) |
Abdominal distension |
14/293 (4.78%) |
9/286 (3.15%) |
Dry mouth |
9/293 (3.07%) |
5/286 (1.75%) |
Hemorrhoids |
6/293 (2.05%) |
4/286 (1.40%) |
Flatulence |
5/293 (1.71%) |
3/286 (1.05%) |
Gastroesophageal reflux disease |
4/293 (1.37%) |
4/286 (1.40%) |
Dysphagia |
5/293 (1.71%) |
2/286 (0.70%) |
Cheilitis |
3/293 (1.02%) |
3/286 (1.05%) |
Epigastric discomfort |
2/293 (0.68%) |
4/286 (1.40%) |
Mouth ulceration |
2/293 (0.68%) |
0/286 (0.00%) |
Esophagitis |
4/293 (1.37%) |
1/286 (0.35%) |
Abdominal discomfort |
2/293 (0.68%) |
3/286 (1.05%) |
Colitis |
3/293 (1.02%) |
1/286 (0.35%) |
Gastritis |
2/293 (0.68%) |
2/286 (0.70%) |
Retching |
1/293 (0.34%) |
3/286 (1.05%) |
Toothache |
3/293 (1.02%) |
1/286 (0.35%) |
Abdominal pain lower |
2/293 (0.68%) |
1/286 (0.35%) |
Anal hemorrhage |
3/293 (1.02%) |
0/286 (0.00%) |
Rectal hemorrhage |
1/293 (0.34%) |
2/286 (0.70%) |
Abdominal tenderness |
2/293 (0.68%) |
0/286 (0.00%) |
Apthous stomatitis |
2/293 (0.68%) |
0/286 (0.00%) |
Ascites |
1/293 (0.34%) |
1/286 (0.35%) |
Gingival pain |
0/293 (0.00%) |
1/286 (0.35%) |
Gingivitis |
1/293 (0.34%) |
1/286 (0.35%) |
Hematochezia |
1/293 (0.34%) |
1/286 (0.35%) |
Oral discomfort |
0/293 (0.00%) |
2/286 (0.70%) |
Oral pain |
2/293 (0.68%) |
0/286 (0.00%) |
Proctalgia |
2/293 (0.68%) |
0/286 (0.00%) |
Abdominal rigidity |
1/293 (0.34%) |
0/286 (0.00%) |
Anorectal discomfort |
1/293 (0.34%) |
0/286 (0.00%) |
Anal fissure |
1/293 (0.34%) |
0/286 (0.00%) |
Anal ulcer |
0/293 (0.00%) |
1/286 (0.35%) |
Diabetic gastropathy |
1/293 (0.34%) |
0/286 (0.00%) |
Fecaloma |
1/293 (0.34%) |
0/286 (0.00%) |
Gastric disorder |
0/293 (0.00%) |
1/286 (0.35%) |
Gastrointestinal pain |
0/293 (0.00%) |
1/286 (0.35%) |
Gastrointestinal toxicity |
1/293 (0.34%) |
0/286 (0.00%) |
Gingival bleeding |
0/293 (0.00%) |
1/286 (0.35%) |
Glossodynia |
1/293 (0.34%) |
0/286 (0.00%) |
Hemorrhoidal hemorrhage |
1/293 (0.34%) |
0/286 (0.00%) |
Hiatus hernia |
0/293 (0.00%) |
1/286 (0.35%) |
Hyperchlorhydria |
1/293 (0.34%) |
0/286 (0.00%) |
Hypoaesthesia oral |
1/293 (0.34%) |
0/286 (0.00%) |
Ileus |
1/293 (0.34%) |
0/286 (0.00%) |
Impaired gastric emptying |
1/293 (0.34%) |
0/286 (0.00%) |
Intestinal ischemia |
1/293 (0.34%) |
0/286 (0.00%) |
Lip dry |
0/293 (0.00%) |
1/286 (0.35%) |
Lip edema |
1/293 (0.34%) |
0/286 (0.00%) |
Loose tooth |
0/293 (0.00%) |
1/286 (0.35%) |
Melena |
1/293 (0.34%) |
0/286 (0.00%) |
Odynophagia |
1/293 (0.34%) |
0/286 (0.00%) |
Esophageal discomfort |
1/293 (0.34%) |
0/286 (0.00%) |
Pancreatitis |
0/293 (0.00%) |
1/286 (0.35%) |
Parasthesia oral |
1/293 (0.34%) |
0/286 (0.00%) |
Reflux gastritis |
0/293 (0.00%) |
1/286 (0.35%) |
Subileus |
1/293 (0.34%) |
0/286 (0.00%) |
Tongue pigmentation |
1/293 (0.34%) |
0/286 (0.00%) |
Tongue ulceration |
1/293 (0.34%) |
0/286 (0.00%) |
General disorders |
|
|
Fatigue |
65/293 (22.18%) |
61/286 (21.33%) |
Asthenia |
62/293 (21.16%) |
36/286 (12.59%) |
Pyrexia |
32/293 (10.92%) |
33/286 (11.54%) |
Mucosal inflammation |
38/293 (12.97%) |
9/286 (3.15%) |
Edema perpheral |
18/293 (6.14%) |
19/286 (6.64%) |
Pain |
19/293 (6.48%) |
16/286 (5.59%) |
Chest pain |
19/293 (6.48%) |
14/286 (4.90%) |
Chills |
6/293 (2.05%) |
8/286 (2.80%) |
Malaise |
6/293 (2.05%) |
7/286 (2.45%) |
Chest discomfort |
6/293 (2.05%) |
4/286 (1.40%) |
Axillary pain |
4/293 (1.37%) |
4/286 (1.40%) |
Influenza like illness |
4/293 (1.37%) |
5/286 (1.75%) |
Face edema |
4/293 (1.37%) |
2/286 (0.70%) |
Edema |
3/293 (1.02%) |
3/286 (1.05%) |
Catheter site pain |
1/293 (0.34%) |
2/286 (0.70%) |
Inflammation |
3/293 (1.02%) |
0/286 (0.00%) |
Adverse drug reaction |
0/293 (0.00%) |
2/286 (0.70%) |
Discomfort |
0/293 (0.00%) |
2/286 (0.70%) |
Injection site reaction |
1/293 (0.34%) |
1/286 (0.35%) |
Irritability |
0/293 (0.00%) |
2/286 (0.70%) |
Breakthrough pain |
1/293 (0.34%) |
0/286 (0.00%) |
Catheter site inflammation |
1/293 (0.34%) |
0/286 (0.00%) |
Catheter site related reaction |
1/293 (0.34%) |
0/286 (0.00%) |
Death |
0/293 (0.00%) |
1/286 (0.35%) |
Early satiety |
0/293 (0.00%) |
1/286 (0.35%) |
Extravasation |
1/293 (0.34%) |
0/286 (0.00%) |
Facial pain |
1/293 (0.34%) |
0/286 (0.00%) |
Granuloma |
0/293 (0.00%) |
1/286 (0.35%) |
Implant site scar |
1/293 (0.34%) |
0/286 (0.00%) |
Infusion site extravasation |
0/293 (0.00%) |
1/286 (0.35%) |
Infusion site edema |
0/293 (0.00%) |
1/286 (0.35%) |
Infusion site pain |
0/293 (0.00%) |
1/286 (0.35%) |
Local swelling |
0/293 (0.00%) |
1/286 (0.35%) |
Localized edema |
1/293 (0.34%) |
0/286 (0.00%) |
Non-cardiac chest pain |
0/293 (0.00%) |
1/286 (0.35%) |
Performance status decreased |
1/293 (0.34%) |
0/286 (0.00%) |
Vessel puncture site pain |
1/293 (0.34%) |
0/286 (0.00%) |
Thirst |
1/293 (0.34%) |
0/286 (0.00%) |
Vessel puncture site reaction |
1/293 (0.34%) |
0/286 (0.00%) |
Generalized edema |
0/293 (0.00%) |
1/286 (0.35%) |
Injection site pain |
1/293 (0.34%) |
0/286 (0.00%) |
Hepatobiliary disorders |
|
|
Hyperbilirubinemia |
6/293 (2.05%) |
4/286 (1.40%) |
Jaundice |
2/293 (0.68%) |
1/286 (0.35%) |
Cholecystitis |
2/293 (0.68%) |
0/286 (0.00%) |
Hepatotoxicity |
1/293 (0.34%) |
1/286 (0.35%) |
Cholecystitis chronic |
0/293 (0.00%) |
1/286 (0.35%) |
Cholelithiasis |
1/293 (0.34%) |
0/286 (0.00%) |
Jaundice cholestatic |
0/293 (0.00%) |
1/286 (0.35%) |
Immune system disorders |
|
|
Hypersensitivity |
11/293 (3.75%) |
3/286 (1.05%) |
Drug hypersensitivity |
3/293 (1.02%) |
1/286 (0.35%) |
Anaphylactic reaction |
1/293 (0.34%) |
1/286 (0.35%) |
Anaphylactic shock |
1/293 (0.34%) |
0/286 (0.00%) |
Multiple allergies |
0/293 (0.00%) |
1/286 (0.35%) |
Contrast media allergy |
1/293 (0.34%) |
0/286 (0.00%) |
Infections and infestations |
|
|
Nasopharyngitis |
17/293 (5.80%) |
7/286 (2.45%) |
Upper respiratory tract infection |
8/293 (2.73%) |
15/286 (5.24%) |
Urinary tract infection |
15/293 (5.12%) |
8/286 (2.80%) |
Influenza |
5/293 (1.71%) |
9/286 (3.15%) |
Pharyngitis |
9/293 (3.07%) |
3/286 (1.05%) |
Cellulitis |
4/293 (1.37%) |
5/286 (1.75%) |
Rhinitis |
7/293 (2.39%) |
2/286 (0.70%) |
Pneumonia |
4/293 (1.37%) |
4/286 (1.40%) |
Bronchitis |
5/293 (1.71%) |
4/286 (1.40%) |
Infection |
6/293 (2.05%) |
1/286 (0.35%) |
Respiratory tract infection |
5/293 (1.71%) |
2/286 (0.70%) |
Cystitis |
2/293 (0.68%) |
4/286 (1.40%) |
Herpes simplex |
1/293 (0.34%) |
1/286 (0.35%) |
Herpes zoster |
3/293 (1.02%) |
3/286 (1.05%) |
Oral candidiasis |
4/293 (1.37%) |
2/286 (0.70%) |
Device related infection |
2/293 (0.68%) |
3/286 (1.05%) |
Folliculitis |
3/293 (1.02%) |
2/286 (0.70%) |
Oral herpes |
5/293 (1.71%) |
0/286 (0.00%) |
Acarodermatitis |
4/293 (1.37%) |
0/286 (0.00%) |
Fungal infection |
2/293 (0.68%) |
1/286 (0.35%) |
Laryngitis |
1/293 (0.34%) |
3/286 (1.05%) |
Lung infection |
1/293 (0.34%) |
3/286 (1.05%) |
Paronychia |
5/293 (1.71%) |
0/286 (0.00%) |
Breast infection |
0/293 (0.00%) |
3/286 (1.05%) |
Lower respiratory tract infection |
2/293 (0.68%) |
1/286 (0.35%) |
Nail infection |
3/293 (1.02%) |
0/286 (0.00%) |
Sepsis |
2/293 (0.68%) |
1/286 (0.35%) |
Sinusitis |
1/293 (0.34%) |
2/286 (0.70%) |
Tonsillitis |
3/293 (1.02%) |
0/286 (0.00%) |
Candidiasis |
2/293 (0.68%) |
0/286 (0.00%) |
Catheter site infection |
1/293 (0.34%) |
1/286 (0.35%) |
Gastroenteritis |
2/293 (0.68%) |
0/286 (0.00%) |
Kidney infection |
2/293 (0.68%) |
0/286 (0.00%) |
Lymphangitis |
2/293 (0.68%) |
0/286 (0.00%) |
Otiits externa |
2/293 (0.68%) |
0/286 (0.00%) |
Otitis media chronic |
2/293 (0.68%) |
0/286 (0.00%) |
Respiratory tract infection viral |
0/293 (0.00%) |
2/286 (0.70%) |
Septic shock |
2/293 (0.68%) |
0/286 (0.00%) |
Skin infection |
0/293 (0.00%) |
2/286 (0.70%) |
Staphylococcal infection |
1/293 (0.34%) |
1/286 (0.35%) |
Viral infection |
2/293 (0.68%) |
0/286 (0.00%) |
Vulvovaginal mycotic infection |
2/293 (0.68%) |
0/286 (0.00%) |
Breast abscess |
0/293 (0.00%) |
1/286 (0.35%) |
Bronchopneumonia |
0/293 (0.00%) |
1/286 (0.35%) |
Catheter site cellulitis |
1/293 (0.34%) |
0/286 (0.00%) |
Clostridial infection |
0/293 (0.00%) |
1/286 (0.35%) |
Clostridium difficile colitis |
1/293 (0.34%) |
0/286 (0.00%) |
Enterocolitis infection |
1/293 (0.34%) |
0/286 (0.00%) |
Epstein-Barr virus infection |
1/293 (0.34%) |
0/286 (0.00%) |
Erysipelas |
1/293 (0.34%) |
0/286 (0.00%) |
Furuncle |
1/293 (0.34%) |
0/286 (0.00%) |
Gallbladder abscess |
1/293 (0.34%) |
0/286 (0.00%) |
Gastrointestinal fungal infection |
1/293 (0.34%) |
0/286 (0.00%) |
Fungal skin infection |
0/293 (0.00%) |
3/286 (1.05%) |
Genital candidiasis |
1/293 (0.34%) |
0/286 (0.00%) |
Klebsiella infection |
1/293 (0.34%) |
0/286 (0.00%) |
Localized infection |
1/293 (0.34%) |
0/286 (0.00%) |
Omphalitis |
1/293 (0.34%) |
0/286 (0.00%) |
Oral fungal infection |
1/293 (0.34%) |
0/286 (0.00%) |
Pneumonia primary atypical |
1/293 (0.34%) |
0/286 (0.00%) |
Postoperative wound infection |
1/293 (0.34%) |
0/286 (0.00%) |
Pyelonephritis |
0/293 (0.00%) |
1/286 (0.35%) |
Subcutaneous abscess |
1/293 (0.34%) |
0/286 (0.00%) |
Tooth abscess |
1/293 (0.34%) |
0/286 (0.00%) |
Tuberculosis |
0/293 (0.00%) |
1/286 (0.35%) |
Urosepsis |
0/293 (0.00%) |
1/286 (0.35%) |
Vaginal infection |
1/293 (0.34%) |
0/286 (0.00%) |
Viral rash |
1/293 (0.34%) |
0/286 (0.00%) |
Viral upper respiratory tract infection |
1/293 (0.34%) |
0/286 (0.00%) |
Injury, poisoning and procedural complications |
|
|
Upper limb fracture |
0/293 (0.00%) |
1/286 (0.35%) |
Wound secretion |
1/293 (0.34%) |
0/286 (0.00%) |
Investigations |
|
|
Alanine aminotransferase increased |
27/293 (9.22%) |
23/286 (8.04%) |
Aspartete aminotransferase increased |
22/293 (7.51%) |
20/286 (6.99%) |
Blood alkaline phosphatase increased |
19/293 (6.48%) |
19/286 (6.64%) |
Weight decreased |
17/293 (5.80%) |
14/286 (4.90%) |
Ejection fraction decreased |
6/293 (2.05%) |
6/286 (2.10%) |
Hemoglobin decreased |
8/293 (2.73%) |
4/286 (1.40%) |
Blood urea increased |
2/293 (0.68%) |
3/286 (1.05%) |
Weight increased |
1/293 (0.34%) |
9/286 (3.15%) |
Neutrophil count decreased |
5/293 (1.71%) |
3/286 (1.05%) |
White blood cell count decreased |
5/293 (1.71%) |
1/286 (0.35%) |
Body temperature increased |
2/293 (0.68%) |
3/286 (1.05%) |
Gamma-glutamyltransferase increased |
3/293 (1.02%) |
2/286 (0.70%) |
Blood albumin decreased |
3/293 (1.02%) |
1/286 (0.35%) |
Blood creatinine increased |
2/293 (0.68%) |
2/286 (0.70%) |
Blood lactate dehydogenase increased |
2/293 (0.68%) |
2/286 (0.70%) |
Blood bilirubin increased |
2/293 (0.68%) |
1/286 (0.35%) |
Blood potassium decreased |
2/293 (0.68%) |
1/286 (0.35%) |
Blood glucose increased |
1/293 (0.34%) |
1/286 (0.35%) |
Blood uric acid increased |
0/293 (0.00%) |
2/286 (0.70%) |
International normalized ratio increased |
2/293 (0.68%) |
0/286 (0.00%) |
Activated partial thromboplastin time prolonged |
1/293 (0.34%) |
0/286 (0.00%) |
Blood bilirubin decreased |
1/293 (0.34%) |
0/286 (0.00%) |
Blood calcium decreased |
1/293 (0.34%) |
0/286 (0.00%) |
Blood homocysteine increased |
1/293 (0.34%) |
0/286 (0.00%) |
Blood pressure increased |
1/293 (0.34%) |
0/286 (0.00%) |
Blood sodium increased |
1/293 (0.34%) |
0/286 (0.00%) |
Blood urine present |
1/293 (0.34%) |
0/286 (0.00%) |
Hemoglobin |
1/293 (0.34%) |
0/286 (0.00%) |
Heart rate irregular |
1/293 (0.34%) |
0/286 (0.00%) |
Platelet count decreased |
0/293 (0.00%) |
1/286 (0.35%) |
Prothrombin level decreased |
1/293 (0.34%) |
0/286 (0.00%) |
Prothrombin time prolonged |
1/293 (0.34%) |
0/286 (0.00%) |
White blood cell count increased |
1/293 (0.34%) |
0/286 (0.00%) |
Metabolism and nutrition disorders |
|
|
Decreased appetite |
50/293 (17.06%) |
32/286 (11.19%) |
Hypercalcemia |
7/293 (2.39%) |
8/286 (2.80%) |
Hyperglycemia |
7/293 (2.39%) |
8/286 (2.80%) |
Dehydration |
12/293 (4.10%) |
2/286 (0.70%) |
Hypokalemia |
12/293 (4.10%) |
2/286 (0.70%) |
Hyperuricemia |
5/293 (1.71%) |
7/286 (2.45%) |
Hyponatremia |
4/293 (1.37%) |
2/286 (0.70%) |
Hyperkalemia |
3/293 (1.02%) |
3/286 (1.05%) |
Hypoalbuminemia |
3/293 (1.02%) |
2/286 (0.70%) |
Hypocalcemia |
3/293 (1.02%) |
2/286 (0.70%) |
Hypernatremia |
2/293 (0.68%) |
3/286 (1.05%) |
Hypoglycemia |
2/293 (0.68%) |
2/286 (0.70%) |
Hypercholesterolemia |
2/293 (0.68%) |
0/286 (0.00%) |
Diabetes mellitus |
0/293 (0.00%) |
1/286 (0.35%) |
Fluid overload |
0/293 (0.00%) |
1/286 (0.35%) |
Hyperchloremia |
0/293 (0.00%) |
1/286 (0.35%) |
Hyperphagia |
0/293 (0.00%) |
1/286 (0.35%) |
Hyperproteinemia |
1/293 (0.34%) |
0/286 (0.00%) |
Hypomagnesemia |
1/293 (0.34%) |
0/286 (0.00%) |
Hypophosphatemia |
1/293 (0.34%) |
0/286 (0.00%) |
Hypoproteinemia |
0/293 (0.00%) |
1/286 (0.35%) |
Hypovolemia |
1/293 (0.34%) |
0/286 (0.00%) |
Tumor lysis syndrome |
1/293 (0.34%) |
0/286 (0.00%) |
Tetany |
1/293 (0.34%) |
0/286 (0.00%) |
Musculoskeletal and connective tissue disorders |
|
|
Myalgia |
94/293 (32.08%) |
74/286 (25.87%) |
Arthralgia |
70/293 (23.89%) |
58/286 (20.28%) |
Pain in extremity |
50/293 (17.06%) |
50/286 (17.48%) |
Bone pain |
34/293 (11.60%) |
32/286 (11.19%) |
Back pain |
26/293 (8.87%) |
29/286 (10.14%) |
Musculoskeletal pain |
23/293 (7.85%) |
27/286 (9.44%) |
Musculoskeletal chest pain |
3/293 (1.02%) |
12/286 (4.20%) |
Muscular weakness |
8/293 (2.73%) |
4/286 (1.40%) |
Neck pain |
6/293 (2.05%) |
4/286 (1.40%) |
Muscle spasms |
4/293 (1.37%) |
5/286 (1.75%) |
Groin pain |
2/293 (0.68%) |
2/286 (0.70%) |
Musculoskeletal discomfort |
2/293 (0.68%) |
2/286 (0.70%) |
Musculoskeletal stiffness |
2/293 (0.68%) |
1/286 (0.35%) |
Arthritis |
0/293 (0.00%) |
2/286 (0.70%) |
Flank pain |
1/293 (0.34%) |
1/286 (0.35%) |
Pain in jaw |
1/293 (0.34%) |
1/286 (0.35%) |
Pathological fracture |
1/293 (0.34%) |
1/286 (0.35%) |
Intervertebral disc disorder |
0/293 (0.00%) |
1/286 (0.35%) |
Joint effusion |
1/293 (0.34%) |
0/286 (0.00%) |
Joint swelling |
0/293 (0.00%) |
1/286 (0.35%) |
Myopathy |
0/293 (0.00%) |
1/286 (0.35%) |
Myositis |
0/293 (0.00%) |
1/286 (0.35%) |
Nodule on extremity |
0/293 (0.00%) |
1/286 (0.35%) |
Osteoporosis |
0/293 (0.00%) |
1/286 (0.35%) |
Sensation of heaviness |
0/293 (0.00%) |
1/286 (0.35%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
Tumor pain |
2/293 (0.68%) |
5/286 (1.75%) |
Breast cancer |
0/293 (0.00%) |
1/286 (0.35%) |
Hemangioma |
0/293 (0.00%) |
1/286 (0.35%) |
Metastases to central nervous system |
1/293 (0.34%) |
0/286 (0.00%) |
Metastases to liver |
1/293 (0.34%) |
0/286 (0.00%) |
Pyogenic granuloma |
1/293 (0.34%) |
0/286 (0.00%) |
Salivary gland adenoma |
1/293 (0.34%) |
0/286 (0.00%) |
Squamous cell carcinoma |
1/293 (0.34%) |
0/286 (0.00%) |
Tumor hemorrhage |
1/293 (0.34%) |
0/286 (0.00%) |
Uterine leiomyoma |
1/293 (0.34%) |
0/286 (0.00%) |
Nervous system disorders |
|
|
Peripheral sensory neuropathy |
48/293 (16.38%) |
54/286 (18.88%) |
Paraesthesia |
43/293 (14.68%) |
42/286 (14.69%) |
Headache |
32/293 (10.92%) |
30/286 (10.49%) |
Neuropathy peripheral |
54/293 (18.43%) |
32/286 (11.19%) |
Dysgeusia |
12/293 (4.10%) |
11/286 (3.85%) |
Dizziness |
13/293 (4.44%) |
9/286 (3.15%) |
Hypoaesthesia |
11/293 (3.75%) |
10/286 (3.50%) |
Polyneuropathy |
9/293 (3.07%) |
3/286 (1.05%) |
Peripheral motor neuropathy |
8/293 (2.73%) |
4/286 (1.40%) |
Neuralgia |
3/293 (1.02%) |
4/286 (1.40%) |
Memory impairment |
3/293 (1.02%) |
3/286 (1.05%) |
Syncope |
3/293 (1.02%) |
2/286 (0.70%) |
Convulsion |
2/293 (0.68%) |
1/286 (0.35%) |
Neurotoxicity |
1/293 (0.34%) |
2/286 (0.70%) |
Somnolence |
2/293 (0.68%) |
1/286 (0.35%) |
Tremor |
1/293 (0.34%) |
2/286 (0.70%) |
Cerebral infarction |
1/293 (0.34%) |
1/286 (0.35%) |
Disturbance in attention |
1/293 (0.34%) |
1/286 (0.35%) |
Hemiplegia |
1/293 (0.34%) |
1/286 (0.35%) |
Migraine |
1/293 (0.34%) |
1/286 (0.35%) |
Restless legs syndrome |
2/293 (0.68%) |
0/286 (0.00%) |
Sinus headache |
1/293 (0.34%) |
1/286 (0.35%) |
Aphasia |
1/293 (0.34%) |
0/286 (0.00%) |
Aphonia |
1/293 (0.34%) |
0/286 (0.00%) |
Brain edema |
1/293 (0.34%) |
0/286 (0.00%) |
Carpal tunnel syndrome |
0/293 (0.00%) |
1/286 (0.35%) |
Cerebrovascular disorder |
1/293 (0.34%) |
0/286 (0.00%) |
Coma hepatic |
0/293 (0.00%) |
1/286 (0.35%) |
Convulsions local |
0/293 (0.00%) |
1/286 (0.35%) |
Depressed level of consiousness |
0/293 (0.00%) |
1/286 (0.35%) |
Dysaesthesia |
1/293 (0.34%) |
0/286 (0.00%) |
Epilepsy |
0/293 (0.00%) |
1/286 (0.35%) |
Facial palsy |
0/293 (0.00%) |
1/286 (0.35%) |
Hyperaesthesia |
0/293 (0.00%) |
1/286 (0.35%) |
Hypersomnia |
1/293 (0.34%) |
0/286 (0.00%) |
Hyporeflexia |
0/293 (0.00%) |
1/286 (0.35%) |
Intracranial pressure increased |
1/293 (0.34%) |
0/286 (0.00%) |
Lethargy |
1/293 (0.34%) |
0/286 (0.00%) |
Loss of consciousness |
1/293 (0.34%) |
0/286 (0.00%) |
Lumbar radiculopathy |
0/293 (0.00%) |
1/286 (0.35%) |
Mental impairment |
1/293 (0.34%) |
0/286 (0.00%) |
Motor dysfunction |
1/293 (0.34%) |
0/286 (0.00%) |
Neuritis |
0/293 (0.00%) |
1/286 (0.35%) |
Paraparesis |
0/293 (0.00%) |
1/286 (0.35%) |
Parosmia |
1/293 (0.34%) |
0/286 (0.00%) |
Peripheral sensorimotor neurophathy |
0/293 (0.00%) |
1/286 (0.35%) |
Sciatica |
0/293 (0.00%) |
1/286 (0.35%) |
Sensory loss |
1/293 (0.34%) |
0/286 (0.00%) |
Psychiatric disorders |
|
|
Insomnia |
34/293 (11.60%) |
29/286 (10.14%) |
Anxiety |
13/293 (4.44%) |
13/286 (4.55%) |
Depression |
10/293 (3.41%) |
13/286 (4.55%) |
Depressed mood |
4/293 (1.37%) |
4/286 (1.40%) |
Confusional state |
2/293 (0.68%) |
3/286 (1.05%) |
Restlessness |
1/293 (0.34%) |
2/286 (0.70%) |
Hallucination |
1/293 (0.34%) |
1/286 (0.35%) |
Mood altered |
2/293 (0.68%) |
0/286 (0.00%) |
Eating disorder |
1/293 (0.34%) |
0/286 (0.00%) |
Emotional distress |
0/293 (0.00%) |
1/286 (0.35%) |
Mental status changes |
0/293 (0.00%) |
1/286 (0.35%) |
Nervousness |
1/293 (0.34%) |
0/286 (0.00%) |
Panic attack |
1/293 (0.34%) |
0/286 (0.00%) |
Personality change |
1/293 (0.34%) |
0/286 (0.00%) |
Personality disorder |
1/293 (0.34%) |
0/286 (0.00%) |
Psychotic disorder |
0/293 (0.00%) |
1/286 (0.35%) |
Suicidal ideation |
1/293 (0.34%) |
0/286 (0.00%) |
Renal and urinary disorders |
|
|
Dysuria |
6/293 (2.05%) |
2/286 (0.70%) |
Hematuria |
3/293 (1.02%) |
0/286 (0.00%) |
Urinary incontinence |
1/293 (0.34%) |
3/286 (1.05%) |
Hydronephrosis |
1/293 (0.34%) |
2/286 (0.70%) |
Polyuria |
2/293 (0.68%) |
0/286 (0.00%) |
Enuresis |
0/293 (0.00%) |
1/286 (0.35%) |
Micturition disorder |
1/293 (0.34%) |
0/286 (0.00%) |
Pollakiuria |
0/293 (0.00%) |
1/286 (0.35%) |
Renal colic |
1/293 (0.34%) |
0/286 (0.00%) |
Renal failure acute |
1/293 (0.34%) |
0/286 (0.00%) |
Urinary retention |
0/293 (0.00%) |
1/286 (0.35%) |
Respiratory, thoracic and mediastinal disorders |
|
|
Cough |
33/293 (11.26%) |
42/286 (14.69%) |
Dyspnoea |
29/293 (9.90%) |
28/286 (9.79%) |
Oropharyngeal pain |
12/293 (4.10%) |
10/286 (3.50%) |
Epistaxis |
13/293 (4.44%) |
4/286 (1.40%) |
Dysphonia |
8/293 (2.73%) |
6/286 (2.10%) |
Productive cough |
5/293 (1.71%) |
2/286 (0.70%) |
Dyspnoea exertional |
3/293 (1.02%) |
1/286 (0.35%) |
Rhinitis allergic |
2/293 (0.68%) |
2/286 (0.70%) |
Hemoptysis |
0/293 (0.00%) |
3/286 (1.05%) |
Nasal congestion |
1/293 (0.34%) |
1/286 (0.35%) |
Nasal dryness |
2/293 (0.68%) |
1/286 (0.35%) |
Wheezing |
1/293 (0.34%) |
2/286 (0.70%) |
Asthma |
1/293 (0.34%) |
1/286 (0.35%) |
Bronchospasm |
1/293 (0.34%) |
1/286 (0.35%) |
Hypoxia |
0/293 (0.00%) |
3/286 (1.05%) |
Increased upper airway secretion |
1/293 (0.34%) |
1/286 (0.35%) |
Nasal inflammation |
2/293 (0.68%) |
0/286 (0.00%) |
Pharyngeal erythema |
1/293 (0.34%) |
1/286 (0.35%) |
Pleural effusion |
1/293 (0.34%) |
1/286 (0.35%) |
Pulmonary embolism |
2/293 (0.68%) |
0/286 (0.00%) |
Pleuritic pain |
1/293 (0.34%) |
0/286 (0.00%) |
Atelectasis |
0/293 (0.00%) |
1/286 (0.35%) |
Bronchostenosis |
0/293 (0.00%) |
1/286 (0.35%) |
Hemothorax |
0/293 (0.00%) |
1/286 (0.35%) |
Lung infiltration |
0/293 (0.00%) |
1/286 (0.35%) |
Nasal discomfort |
1/293 (0.34%) |
0/286 (0.00%) |
Nasal ulcer |
0/293 (0.00%) |
1/286 (0.35%) |
Pain respiration |
1/293 (0.34%) |
0/286 (0.00%) |
Pleural fibrosis |
1/293 (0.34%) |
0/286 (0.00%) |
Pneumonitis |
0/293 (0.00%) |
1/286 (0.35%) |
Pulmonary hemorrhage |
1/293 (0.34%) |
0/286 (0.00%) |
Pulmonary edema |
1/293 (0.34%) |
0/286 (0.00%) |
Rales |
1/293 (0.34%) |
0/286 (0.00%) |
Respiratory disorder |
1/293 (0.34%) |
0/286 (0.00%) |
Rhinorrhoea |
1/293 (0.34%) |
0/286 (0.00%) |
Sinus congestion |
0/293 (0.00%) |
1/286 (0.35%) |
Sputum discoloured |
1/293 (0.34%) |
0/286 (0.00%) |
Upper airway obstruction |
0/293 (0.00%) |
1/286 (0.35%) |
Skin and subcutaneous tissue disorders |
|
|
Alopecia |
153/293 (52.22%) |
183/286 (63.99%) |
Rash |
145/293 (49.49%) |
66/286 (23.08%) |
Pruritus |
46/293 (15.70%) |
37/286 (12.94%) |
Dry skin |
13/293 (4.44%) |
8/286 (2.80%) |
Nail disorder |
8/293 (2.73%) |
5/286 (1.75%) |
Pain of skin |
4/293 (1.37%) |
4/286 (1.40%) |
Skin hyperpigmentation |
7/293 (2.39%) |
1/286 (0.35%) |
Hyperhidrosis |
3/293 (1.02%) |
3/286 (1.05%) |
Rash generalized |
3/293 (1.02%) |
2/286 (0.70%) |
Palmar-plantar erythrodysaesthesia syndrome |
5/293 (1.71%) |
1/286 (0.35%) |
Urticaria |
2/293 (0.68%) |
3/286 (1.05%) |
Ecchymosis |
1/293 (0.34%) |
2/286 (0.70%) |
Rash erythematous |
2/293 (0.68%) |
1/286 (0.35%) |
Dermatitis allergic |
2/293 (0.68%) |
1/286 (0.35%) |
Nail discoloration |
1/293 (0.34%) |
1/286 (0.35%) |
Night sweats |
1/293 (0.34%) |
1/286 (0.35%) |
Pruritus generalized |
0/293 (0.00%) |
2/286 (0.70%) |
Skin exfoliation |
0/293 (0.00%) |
2/286 (0.70%) |
Skin fissures |
1/293 (0.34%) |
1/286 (0.35%) |
Blister |
0/293 (0.00%) |
1/286 (0.35%) |
Butterfly rash |
0/293 (0.00%) |
1/286 (0.35%) |
Cold sweat |
0/293 (0.00%) |
1/286 (0.35%) |
Erythema multiforme |
1/293 (0.34%) |
0/286 (0.00%) |
Hemorrhage subcutaneous |
0/293 (0.00%) |
1/286 (0.35%) |
Hair growth abnormal |
1/293 (0.34%) |
0/286 (0.00%) |
Hirsutism |
1/293 (0.34%) |
0/286 (0.00%) |
Hypertrichosis |
1/293 (0.34%) |
0/286 (0.00%) |
Hypoaesthesia facial |
1/293 (0.34%) |
0/286 (0.00%) |
Ingrowing nail |
1/293 (0.34%) |
0/286 (0.00%) |
Intertrigo |
0/293 (0.00%) |
1/286 (0.35%) |
Madarosis |
0/293 (0.00%) |
1/286 (0.35%) |
Onychalgia |
1/293 (0.34%) |
0/286 (0.00%) |
Onycholysis |
1/293 (0.34%) |
0/286 (0.00%) |
Periorbital edema |
1/293 (0.34%) |
0/286 (0.00%) |
Rosacea |
1/293 (0.34%) |
0/286 (0.00%) |
Skin chapped |
1/293 (0.34%) |
0/286 (0.00%) |
Skin discomfort |
1/293 (0.34%) |
0/286 (0.00%) |
Skin disorder |
0/293 (0.00%) |
1/286 (0.35%) |
Skin lesion |
1/293 (0.34%) |
0/286 (0.00%) |
Swelling face |
1/293 (0.34%) |
0/286 (0.00%) |
Social circumstances |
|
|
Immobile |
0/293 (0.00%) |
1/286 (0.35%) |
Indicates events were collected by systematic assessment
Term from vocabulary, MedDRA
|