Adverse events in children treated for MDR-TB
| Adverse event | Grade 0 | Grade 1 | Grade 2 | Grade 3 | Grade 4* | Total |
|---|---|---|---|---|---|---|
| Joint, muscle or bone pain | 122 | 11 | 2 | 1 | 1 | 137 |
| Skin rashes | 104 | 30 | 2 | 0 | 1 | 137 |
| Itchy skin | 110 | 24 | 2 | 0 | 1 | 137 |
| Headache | 119 | 16 | 1 | 0 | 0 | 136† |
| Sleep/mood problem | 124 | 9 | 3 | 0 | 1 | 137 |
| Lethargy | 118 | 17 | 1 | 0 | 1 | 137 |
| Visual problem | 132 | 5 | 0 | 0 | 0 | 137 |
| Vomiting | 113 | 20 | 3 | 0 | 1 | 137 |
| Diarrhoea | 125 | 10 | 1 | 0 | 1 | 137 |
| Jaundice | 133 | 1 | 2 | 0 | 1 | 137 |
| Appetite/nausea | 118 | 14 | 3 | 1 | 1 | 137 |
| Hearing loss‡ | 117 | 25 | 142 | |||
| Thyroxine supplementation provided§ | 110 | 32 | 142 |
*One child developed DRESS syndrome after a month on therapy with severe symptoms and signs. All drugs were stopped and it was unclear which drug was responsible. All grade 4 reactions are from this one child. She had culture-confirmed MDR-TB with small lesion in the left upper lobe. At follow-up she remained healthy and culture negative for 3 years.
†One mother felt unable to tell if her child had experienced headache.
‡Hearing loss was not graded but categorised as present or not using ASHA criteria.
§The decision to start thyroxine supplementation was based on elevated thyroid stimulating hormone and low free T4 levels.
ASHA, American Speech-Language-Hearing Association; DRESS, drug reaction with eosinophilia and systemic symptoms; MDR, multidrug resistant; TB, tuberculosis.