Table 3.
Positive triggers and related adverse drug reactions observed during Phase I
| Trigger | ADRs | Number of ADRs detected |
|---|---|---|
| DT | ||
| DT1 - Sudden stoppage of drug | Diarrhea | 4 |
| Headache | 3 | |
| Rash | 3 | |
| Peeling of skin | 1 | |
| Anemia | 1 | |
| Loss of appetite | 1 | |
| Increased serum keratinize | 1 | |
| Hypokalemia | 1 | |
| Muscle pain | 1 | |
| Itching | 1 | |
| Delirium | 1 | |
| Cough | 1 | |
| Vomiting | 1 | |
| DT2 - New drug administration | Diarrhea | 3 |
| Neuropathy | 1 | |
| Dry cough | 2 | |
| Hypokalemia | 1 | |
| Vomiting | 1 | |
| DT3 - Antihistamines | Rash | 3 |
| DT4 - Antiemetics | Vomiting | 1 |
| DT5 - Antidiarrheal | Diarrhea | 6 |
| DT6 - Antacids | Gastritis | 2 |
| DT7 - Laxatives | Constipation | 1 |
| DT15 - IV fluids started/dose increased | Hypoglycemia | 1 |
| DT19 - Thrombophob gel | Thrombophlebitis | 4 |
| DT20 - Blood/blood product transfusion | Anemia | 1 |
| Total | 47 | |
| LT | ||
| LT4 - Abrupt drop hemoglobin | Anemia | 2 |
| LT13 - Hypokalemia | Hypokalemia | 2 |
| LT24 - Increased serum keratinize | Increased serum creatinine | 2 |
| Total | 6 | |
| PT | ||
| PT1 - Rash | Rash | 5 |
| PT2 - Pruritus | Pruritus | 2 |
| PT3 - Drowsiness/falls/lethargy | Drowsiness | 1 |
| PT5 - Transfer/reference to other centre | Rash | 1 |
| Pancreatitis | 1 | |
| PT6 - Weight gain | Weight gain | 2 |
| PT7 - Other complaints | Somnolence | 2 |
| Headache | 1 | |
| Dizziness | 1 | |
| Vomiting | 1 | |
| Myalgia | 1 | |
| Loss of appetite | 1 | |
| Metallic taste | 1 | |
| Pedal edema | 1 | |
| Dry cough | 1 | |
| Edema on the face | 1 | |
| Dizziness | 1 | |
| Malaise | 1 | |
| Increased bleeding tendency | 1 | |
| Pancreatitis | 1 | |
| Total | 27 |
DT=Drug trigger, LT=Laboratory trigger, PT=Patient trigger, ADR=Adverse drug reactions, IV=Intravenous