Adverse drug reaction Patients Naranjo score Severity grading Regimen switch/drug substitution Outcome of treatment Number (%)
Death Recovered with disability Recovered fully
Skin rash 100  (26.3) 5-8 Mild None     100 (26.3)
Insomnia   10 (2.6) 5-8 Mild None       10 (2.6)
Somnolence     7 (1.8) 5-8 Mild None        7 (1.8)
Bad dreams     6 (1.5) >9 Mild None       6 (1.5)
Discoloration of finger nails           10 (2.6) >9 Moderate AZT/3TC/NVP to TDF/FTC/NVP     10 (2.6)  
Proximal muscle pain and weakness 2 (0.5) 1-4 Moderate None       9 (2.4)  
7 (1.9) 1-4 Moderate AZT/3TC/NVP
to TDF/FTC/NVP
Nausea, hypersalivation
and vomiting
129  (33.9) > 9 Moderate None     129 (33.9)
Peripheral neuropathy   12 (3.1) >9 Moderate D4T substituted with AZT     12 (3.1)  
Facial lipodystrophy     6 (1.5) >9 Moderate D4T substituted with  AZT       6 (1.5)  
Palm  hyperpigmentation     2  (0.6) >9 Moderate D4T/3TC/NVP to TDF/FTC/NVP       2  (0.6)  
Anemia  1 (0.2) > 9 Moderate None     25  (6.5)
24(6.3) > 9 Moderate  AZT/3TC/NVP
to TDF/FTC/NVP
2 (0.6) > 9 Severe Removed AZT from AZT+ TDF/FTC+
LPV/r
2 (0.6)    
Steven-Johnson syndrome(SJS)   27  (7.1) >9 Severe NVP substituted  with EFV 1 (0.3)     26  (6.8)
 Diarrhea   18  (4.7) 5-8 Severe None       18  (4.7)
Jaundice   16  (4.2) >9 Severe NVP substituted  with EFV       16  (4.2)
Headache     1  (0.3) 1-4 Severe None       1  (0.3)
Total 380 (100)       3 (0.9) 39 (10.2) 338 (88.9)
Table 4: Causality assessment, severity, drug switch/drug substitution and outcome of treatment of adverse drug reactions.
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