Time Frame |
148 weeks
|
Adverse Event Reporting Description |
[Not Specified]
|
|
Arm/Group Title
|
Nevirapine QD
|
Nevirapine BID
|
Atazanvir/Ritonavir
|
Arm/Group Description |
NVP 400mg QD on a background of the...
|
NVP 200mg BID on a background of th...
|
ATZ/r on a background of the fixed ...
|
Arm/Group Description |
NVP 400mg QD on a background of the fixed combination Truvada®
|
NVP 200mg BID on a background of the fixed combination Truvada®
|
ATZ/r on a background of the fixed combination Truvada®
|
|
|
Nevirapine QD
|
Nevirapine BID
|
Atazanvir/Ritonavir
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
--/-- |
--/-- |
--/-- |
|
|
Nevirapine QD
|
Nevirapine BID
|
Atazanvir/Ritonavir
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
25/188 (13.30%) |
31/188 (16.49%) |
27/193 (13.99%) |
Blood and lymphatic system disorders |
|
|
|
Anaemia |
0/188 (0.00%) |
2/188 (1.06%) |
0/193 (0.00%) |
Neutropenia |
0/188 (0.00%) |
1/188 (0.53%) |
0/193 (0.00%) |
Cardiac disorders |
|
|
|
Acute myocardial infarction |
0/188 (0.00%) |
0/188 (0.00%) |
1/193 (0.52%) |
Angina pectoris |
0/188 (0.00%) |
1/188 (0.53%) |
0/193 (0.00%) |
Angina unstable |
0/188 (0.00%) |
1/188 (0.53%) |
0/193 (0.00%) |
Cardiac failure |
0/188 (0.00%) |
0/188 (0.00%) |
1/193 (0.52%) |
Myocardial infarction |
0/188 (0.00%) |
0/188 (0.00%) |
1/193 (0.52%) |
Myopericarditis |
0/188 (0.00%) |
1/188 (0.53%) |
0/193 (0.00%) |
Endocrine disorders |
|
|
|
Goitre |
1/188 (0.53%) |
0/188 (0.00%) |
0/193 (0.00%) |
Eye disorders |
|
|
|
Retinal detachment |
0/188 (0.00%) |
0/188 (0.00%) |
1/193 (0.52%) |
Gastrointestinal disorders |
|
|
|
Constipation |
1/188 (0.53%) |
0/188 (0.00%) |
0/193 (0.00%) |
Inguinal hernia |
1/188 (0.53%) |
0/188 (0.00%) |
0/193 (0.00%) |
Peritonitis |
0/188 (0.00%) |
1/188 (0.53%) |
0/193 (0.00%) |
General disorders |
|
|
|
Asthenia |
0/188 (0.00%) |
1/188 (0.53%) |
0/193 (0.00%) |
Fatigue |
0/188 (0.00%) |
1/188 (0.53%) |
0/193 (0.00%) |
Multi-organ failure |
1/188 (0.53%) |
0/188 (0.00%) |
0/193 (0.00%) |
Pain |
0/188 (0.00%) |
1/188 (0.53%) |
0/193 (0.00%) |
Puncture site haemorrhage |
1/188 (0.53%) |
0/188 (0.00%) |
0/193 (0.00%) |
Pyrexia |
1/188 (0.53%) |
3/188 (1.60%) |
0/193 (0.00%) |
Hepatobiliary disorders |
|
|
|
Cholecystitis |
0/188 (0.00%) |
0/188 (0.00%) |
1/193 (0.52%) |
Cholecystitis acute |
1/188 (0.53%) |
0/188 (0.00%) |
0/193 (0.00%) |
Cholelithiasis |
0/188 (0.00%) |
3/188 (1.60%) |
0/193 (0.00%) |
Cholestasis |
1/188 (0.53%) |
0/188 (0.00%) |
0/193 (0.00%) |
Immune system disorders |
|
|
|
Drug hypersensitivity |
1/188 (0.53%) |
0/188 (0.00%) |
0/193 (0.00%) |
Infections and infestations |
|
|
|
Abscess jaw |
1/188 (0.53%) |
0/188 (0.00%) |
0/193 (0.00%) |
Anal abscess |
1/188 (0.53%) |
0/188 (0.00%) |
0/193 (0.00%) |
Anogenital warts |
0/188 (0.00%) |
0/188 (0.00%) |
5/193 (2.59%) |
Appendicitis |
0/188 (0.00%) |
1/188 (0.53%) |
0/193 (0.00%) |
Candida pneumonia |
0/188 (0.00%) |
1/188 (0.53%) |
0/193 (0.00%) |
Cerebral toxoplasmosis |
1/188 (0.53%) |
0/188 (0.00%) |
0/193 (0.00%) |
Cryptococcosis |
1/188 (0.53%) |
0/188 (0.00%) |
0/193 (0.00%) |
Cytomegalovirus infection |
0/188 (0.00%) |
0/188 (0.00%) |
1/193 (0.52%) |
Gastroenteritis |
0/188 (0.00%) |
0/188 (0.00%) |
1/193 (0.52%) |
H1N1 influenza |
1/188 (0.53%) |
0/188 (0.00%) |
0/193 (0.00%) |
HIV infection |
0/188 (0.00%) |
1/188 (0.53%) |
0/193 (0.00%) |
Hepatitis A |
0/188 (0.00%) |
0/188 (0.00%) |
2/193 (1.04%) |
Herpes zoster |
1/188 (0.53%) |
0/188 (0.00%) |
0/193 (0.00%) |
Meningitis viral |
0/188 (0.00%) |
0/188 (0.00%) |
1/193 (0.52%) |
Neurosyphilis |
1/188 (0.53%) |
0/188 (0.00%) |
0/193 (0.00%) |
Orchitis |
0/188 (0.00%) |
0/188 (0.00%) |
1/193 (0.52%) |
Papilloma viral infection |
0/188 (0.00%) |
1/188 (0.53%) |
0/193 (0.00%) |
Pneumocystis jiroveci pneumonia |
1/188 (0.53%) |
0/188 (0.00%) |
0/193 (0.00%) |
Pneumonia |
2/188 (1.06%) |
0/188 (0.00%) |
3/193 (1.55%) |
Postoperative wound infection |
1/188 (0.53%) |
0/188 (0.00%) |
0/193 (0.00%) |
Pulmonary tuberculosis |
1/188 (0.53%) |
0/188 (0.00%) |
0/193 (0.00%) |
Salpingitis |
0/188 (0.00%) |
0/188 (0.00%) |
1/193 (0.52%) |
Sepsis |
0/188 (0.00%) |
1/188 (0.53%) |
0/193 (0.00%) |
Sinusitis |
0/188 (0.00%) |
0/188 (0.00%) |
1/193 (0.52%) |
Subcutaneous abscess |
0/188 (0.00%) |
0/188 (0.00%) |
1/193 (0.52%) |
Tuberculosis |
0/188 (0.00%) |
1/188 (0.53%) |
0/193 (0.00%) |
Urinary tract infection |
0/188 (0.00%) |
0/188 (0.00%) |
1/193 (0.52%) |
Injury, poisoning and procedural complications |
|
|
|
Drug exposure during pregnancy |
1/188 (0.53%) |
0/188 (0.00%) |
0/193 (0.00%) |
Fall |
1/188 (0.53%) |
1/188 (0.53%) |
0/193 (0.00%) |
Fracture of penis |
0/188 (0.00%) |
0/188 (0.00%) |
1/193 (0.52%) |
Meniscus lesion |
1/188 (0.53%) |
0/188 (0.00%) |
0/193 (0.00%) |
Multiple injuries |
0/188 (0.00%) |
1/188 (0.53%) |
0/193 (0.00%) |
Rib fracture |
0/188 (0.00%) |
0/188 (0.00%) |
1/193 (0.52%) |
Subdural haematoma |
0/188 (0.00%) |
1/188 (0.53%) |
0/193 (0.00%) |
Upper limb fracture |
1/188 (0.53%) |
2/188 (1.06%) |
0/193 (0.00%) |
Investigations |
|
|
|
Alanine aminotransferase increased |
0/188 (0.00%) |
1/188 (0.53%) |
1/193 (0.52%) |
Aspartate aminotransferase increased |
0/188 (0.00%) |
1/188 (0.53%) |
0/193 (0.00%) |
Blood bilirubin increased |
0/188 (0.00%) |
1/188 (0.53%) |
1/193 (0.52%) |
Blood creatine phosphokinase increased |
0/188 (0.00%) |
0/188 (0.00%) |
1/193 (0.52%) |
Gamma-glutamyltransferase increased |
0/188 (0.00%) |
1/188 (0.53%) |
0/193 (0.00%) |
Haemoglobin decreased |
1/188 (0.53%) |
0/188 (0.00%) |
0/193 (0.00%) |
Transaminases increased |
0/188 (0.00%) |
1/188 (0.53%) |
0/193 (0.00%) |
Musculoskeletal and connective tissue disorders |
|
|
|
Arthralgia |
0/188 (0.00%) |
1/188 (0.53%) |
0/193 (0.00%) |
Back pain |
1/188 (0.53%) |
0/188 (0.00%) |
0/193 (0.00%) |
Flank pain |
1/188 (0.53%) |
0/188 (0.00%) |
0/193 (0.00%) |
Musculoskeletal stiffness |
1/188 (0.53%) |
0/188 (0.00%) |
0/193 (0.00%) |
Myalgia |
1/188 (0.53%) |
0/188 (0.00%) |
0/193 (0.00%) |
Neck pain |
1/188 (0.53%) |
0/188 (0.00%) |
0/193 (0.00%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
|
Basal cell carcinoma |
0/188 (0.00%) |
1/188 (0.53%) |
0/193 (0.00%) |
Bladder neoplasm |
0/188 (0.00%) |
1/188 (0.53%) |
0/193 (0.00%) |
Bone neoplasm |
0/188 (0.00%) |
1/188 (0.53%) |
0/193 (0.00%) |
Hodgkin's disease |
2/188 (1.06%) |
2/188 (1.06%) |
0/193 (0.00%) |
Kaposi's sarcoma |
0/188 (0.00%) |
1/188 (0.53%) |
0/193 (0.00%) |
Lung carcinoma cell type unspecified recurrent |
0/188 (0.00%) |
0/188 (0.00%) |
1/193 (0.52%) |
Lung neoplasm malignant |
0/188 (0.00%) |
0/188 (0.00%) |
1/193 (0.52%) |
Lymphoma |
0/188 (0.00%) |
1/188 (0.53%) |
0/193 (0.00%) |
Myelodysplastic syndrome |
0/188 (0.00%) |
1/188 (0.53%) |
0/193 (0.00%) |
Non-Hodgkin's lymphoma |
0/188 (0.00%) |
2/188 (1.06%) |
0/193 (0.00%) |
Pancreatic carcinoma |
1/188 (0.53%) |
0/188 (0.00%) |
0/193 (0.00%) |
Nervous system disorders |
|
|
|
Carpal tunnel syndrome |
1/188 (0.53%) |
0/188 (0.00%) |
0/193 (0.00%) |
Cerebellar syndrome |
1/188 (0.53%) |
0/188 (0.00%) |
0/193 (0.00%) |
Cerebrovascular accident |
0/188 (0.00%) |
2/188 (1.06%) |
0/193 (0.00%) |
Convulsion |
0/188 (0.00%) |
1/188 (0.53%) |
0/193 (0.00%) |
Epilepsy |
0/188 (0.00%) |
1/188 (0.53%) |
0/193 (0.00%) |
Headache |
1/188 (0.53%) |
0/188 (0.00%) |
1/193 (0.52%) |
Hypoaesthesia |
1/188 (0.53%) |
0/188 (0.00%) |
0/193 (0.00%) |
Neuralgia |
1/188 (0.53%) |
0/188 (0.00%) |
0/193 (0.00%) |
Neuropathy peripheral |
0/188 (0.00%) |
1/188 (0.53%) |
0/193 (0.00%) |
Psychiatric disorders |
|
|
|
Alcohol abuse |
1/188 (0.53%) |
0/188 (0.00%) |
0/193 (0.00%) |
Depression |
1/188 (0.53%) |
0/188 (0.00%) |
0/193 (0.00%) |
Schizophrenia |
0/188 (0.00%) |
1/188 (0.53%) |
0/193 (0.00%) |
Suicide attempt |
1/188 (0.53%) |
0/188 (0.00%) |
0/193 (0.00%) |
Renal and urinary disorders |
|
|
|
Renal failure |
0/188 (0.00%) |
0/188 (0.00%) |
1/193 (0.52%) |
Renal failure acute |
1/188 (0.53%) |
1/188 (0.53%) |
0/193 (0.00%) |
Reproductive system and breast disorders |
|
|
|
Cervical dysplasia |
1/188 (0.53%) |
0/188 (0.00%) |
0/193 (0.00%) |
Ovarian cyst ruptured |
1/188 (0.53%) |
0/188 (0.00%) |
0/193 (0.00%) |
Respiratory, thoracic and mediastinal disorders |
|
|
|
Asthma |
0/188 (0.00%) |
1/188 (0.53%) |
0/193 (0.00%) |
Chronic obstructive pulmonary disease |
0/188 (0.00%) |
0/188 (0.00%) |
1/193 (0.52%) |
Cough |
0/188 (0.00%) |
1/188 (0.53%) |
0/193 (0.00%) |
Dyspnoea |
0/188 (0.00%) |
1/188 (0.53%) |
0/193 (0.00%) |
Interstitial lung disease |
1/188 (0.53%) |
0/188 (0.00%) |
0/193 (0.00%) |
Pleural effusion |
0/188 (0.00%) |
1/188 (0.53%) |
0/193 (0.00%) |
Pleurisy |
0/188 (0.00%) |
0/188 (0.00%) |
1/193 (0.52%) |
Pulmonary oedema |
1/188 (0.53%) |
0/188 (0.00%) |
0/193 (0.00%) |
Skin and subcutaneous tissue disorders |
|
|
|
Rash |
1/188 (0.53%) |
0/188 (0.00%) |
0/193 (0.00%) |
Surgical and medical procedures |
|
|
|
Breast prosthesis implantation |
0/188 (0.00%) |
1/188 (0.53%) |
0/193 (0.00%) |
Mastoidectomy |
0/188 (0.00%) |
0/188 (0.00%) |
1/193 (0.52%) |
Tympanoplasty |
0/188 (0.00%) |
0/188 (0.00%) |
1/193 (0.52%) |
Indicates events were collected by systematic assessment
Term from vocabulary, MedDRA 14.0
|
|
Frequency Threshold for Reporting Other Adverse Events
|
5%
|
|
Nevirapine QD
|
Nevirapine BID
|
Atazanvir/Ritonavir
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
136/188 (72.34%) |
141/188 (75.00%) |
161/193 (83.42%) |
Eye disorders |
|
|
|
Ocular icterus |
0/188 (0.00%) |
0/188 (0.00%) |
14/193 (7.25%) |
Gastrointestinal disorders |
|
|
|
Abdominal pain |
5/188 (2.66%) |
10/188 (5.32%) |
15/193 (7.77%) |
Abdominal pain upper |
9/188 (4.79%) |
14/188 (7.45%) |
13/193 (6.74%) |
Diarrhoea |
29/188 (15.43%) |
33/188 (17.55%) |
47/193 (24.35%) |
Flatulence |
9/188 (4.79%) |
10/188 (5.32%) |
9/193 (4.66%) |
Nausea |
22/188 (11.70%) |
21/188 (11.17%) |
21/193 (10.88%) |
Vomiting |
13/188 (6.91%) |
15/188 (7.98%) |
8/193 (4.15%) |
General disorders |
|
|
|
Fatigue |
11/188 (5.85%) |
11/188 (5.85%) |
12/193 (6.22%) |
Influenza like illness |
10/188 (5.32%) |
6/188 (3.19%) |
9/193 (4.66%) |
Pyrexia |
14/188 (7.45%) |
13/188 (6.91%) |
9/193 (4.66%) |
Hepatobiliary disorders |
|
|
|
Hyperbilirubinaemia |
0/188 (0.00%) |
0/188 (0.00%) |
15/193 (7.77%) |
Jaundice |
0/188 (0.00%) |
0/188 (0.00%) |
40/193 (20.73%) |
Infections and infestations |
|
|
|
Bronchitis |
28/188 (14.89%) |
19/188 (10.11%) |
19/193 (9.84%) |
Gastroenteritis |
8/188 (4.26%) |
14/188 (7.45%) |
8/193 (4.15%) |
Gonorrhoea |
11/188 (5.85%) |
3/188 (1.60%) |
4/193 (2.07%) |
Herpes zoster |
16/188 (8.51%) |
12/188 (6.38%) |
7/193 (3.63%) |
Influenza |
21/188 (11.17%) |
18/188 (9.57%) |
16/193 (8.29%) |
Nasopharyngitis |
41/188 (21.81%) |
36/188 (19.15%) |
40/193 (20.73%) |
Pharyngitis |
10/188 (5.32%) |
10/188 (5.32%) |
12/193 (6.22%) |
Rhinitis |
8/188 (4.26%) |
7/188 (3.72%) |
13/193 (6.74%) |
Sinusitis |
13/188 (6.91%) |
9/188 (4.79%) |
10/193 (5.18%) |
Upper respiratory tract infection |
6/188 (3.19%) |
8/188 (4.26%) |
14/193 (7.25%) |
Investigations |
|
|
|
Blood bilirubin increased |
0/188 (0.00%) |
1/188 (0.53%) |
33/193 (17.10%) |
Musculoskeletal and connective tissue disorders |
|
|
|
Arthralgia |
14/188 (7.45%) |
8/188 (4.26%) |
11/193 (5.70%) |
Back pain |
14/188 (7.45%) |
13/188 (6.91%) |
17/193 (8.81%) |
Myalgia |
12/188 (6.38%) |
10/188 (5.32%) |
9/193 (4.66%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
|
Skin papilloma |
1/188 (0.53%) |
0/188 (0.00%) |
11/193 (5.70%) |
Nervous system disorders |
|
|
|
Headache |
27/188 (14.36%) |
24/188 (12.77%) |
35/193 (18.13%) |
Psychiatric disorders |
|
|
|
Depression |
16/188 (8.51%) |
9/188 (4.79%) |
18/193 (9.33%) |
Respiratory, thoracic and mediastinal disorders |
|
|
|
Cough |
18/188 (9.57%) |
22/188 (11.70%) |
21/193 (10.88%) |
Oropharyngeal pain |
6/188 (3.19%) |
4/188 (2.13%) |
12/193 (6.22%) |
Skin and subcutaneous tissue disorders |
|
|
|
Rash |
25/188 (13.30%) |
31/188 (16.49%) |
23/193 (11.92%) |
Vascular disorders |
|
|
|
Hypertension |
10/188 (5.32%) |
9/188 (4.79%) |
9/193 (4.66%) |
Indicates events were collected by systematic assessment
Term from vocabulary, MedDRA 14.0
|