Table 3 Adverse events experienced since study entry and the action taken

CVS

Hypertension

2

4

Resolved on antihypertensives

Palpitations

2

0

Resolved- no action

Pedal edema

1

2

1 -required diuretics

Digestive

Diarrhoea

2

1

2- resolve on study withdrawal

1- resolve no action

Dyspepsia

1

7

Resolve on H2-R antagonist/PPI*

Excessive weight gain**

7

8

↓ prednisone if accompanied by other AEs

Gastric ulcer

0

1

Resolved on medical management

Increased appetite

1

0

No action

Endocrine

Diabetes requiring insulin

1

1

Controlled on insulin

NIDM new

3

1

Controlled on hypoglycemics & ↓ prednisone

Blurred vision-lens edema

0

1

Resolve on ↓ prednisone

Moon face

1

1

Improved on ↓ prednisone

Mouth ulcers

0

2

Resolve- no dose change

Nervous

Anxiety, insomnia, moody

5

0

Controlled on amitryptaline & ↓ prednisone

Cramps in legs

3

2

Controlled on K+ supplements

Dysesthesiae in feet

0

1

Improved on ↓ prednisone

Fatigue/asthenia

0

1

No action

Headache

0

1

Resolve -no action

Hearing loss

1

0

Resolve on study withdrawal

Tremors

0

2

Intermittent; no action

Respiratory

Pneumonia

1

0

Intravenous antibiotics

Skeletal

Arthralgia

1

2

Intermittent; no action

Skin

Acne/erythema/hirsutism

1

1

Resolve on prednisone reduction/withdrawal

Fungal infection

1

2

Resolve on topical antifungals & ↓ prednisone

Hidradenitis suppurativa

1

0

Oral antibiotics with incision drainage