Monitoring of Suspected Adverse Drug Reactions in Oncology Unit ...

International Journal of Research in Pharmaceutical and Biomedical Sciences ISSN: 2229-3701
Table 4
Adverse event profile encountered in the study population with the frequency of individual events.
Event Count Percentage
1. Abdominal pain (cramps), diarrhea 1 0.34
2. Abdominal pain (cramps) 1 0.34
3. Abdominal pain 2 0.68
4. Acidity 43 14.58
5. Acidity, heartburn 4 1.36
6. Acidity, oral ulceration 1 0.34
7. Anorexia, constipation 1 0.34
8. Anorexia 5 1.69
9. Blepharospasm 3 1.02
10. Chest pain, vomiting 1 0.34
11. Constipation 8 2.71
12. Fever 1 0.34
13. Fever, chills 1 0.34
14. Fever, headache 2 0.68
15. Gastrointestinal discomfort 15 5.08
16. GI ulceration 2 0.68
17. Gum bleeding 2 0.68
18. Hair loss (distressing) 9 3.05
19. Headache, vomiting 1 0.34
20. Headache 2 0.68
21. Insomnia 2 0.68
22. Nausea 1 0.34
23. Nausea, vomiting, anorexia 3 1.02
24. Nausea, vomiting, diarrhea 1 0.34
25. Nausea, vomiting 144 48.81
26. Oral ulceration, stomatitis 4 1.36
27. Oral ulceration 5 1.69
28. Pruritus, skin rash 17 5.76
29. Pruritus 11 3.73
30. Stomatitis, diarrhea 1 0.34
31. Stomatitis 1 0.34
TOTAL 295 100.00
Regarding the severity profile of the ADRs encountered, the data has been tabulated in Table 5. This
severity grading relates to the clinically judged severity of treatment-emergent events in individual cases,
and not to any scoring system or standardized criteria for severity grading for toxicity. A total of 29 of the
295 recorded events (9.83%) were severe. As already noted, hair loss events were recorded only if severe
enough to be distressing to the patients, which in almost all cases meant complete scalp alopecia. Milder
hair loss was universal and was ignored. Although nausea and vomiting was the most frequent adverse
event recorded, it was severe in only 7 of the 149 cases.
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