b. Tabulated list of adverse reactions

Table 2 presents events seen at a higher rate among patients receiving Fuzeon + OB regimen than among patients on the OB alone regimen with an exposure adjusted increase of at least 2 patients with event per 100 patient-years. A statistically significant increase was seen for pneumonia and lymphadenopathy. Most adverse reactions were of mild or moderate intensity. Adverse reactions are listed according to MedDRA system organ class and frequency category. Frequency categories are defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).

Table 2: Adverse reactions attributed to treatment with Fuzeon in studies TORO 1 and TORO 2 combined

System organ class

Frequency
 Adverse reaction
 
Infections and infestations

Common
 

Sinusitis, skin papilloma, influenza, pneumonia, ear infection
 
Blood and lymphatic system disorders

Common
 

Lymphadenopathy
 
Metabolism and nutrition disorders

Common
 

Appetite decreased, anorexia, hypertriglyceridaemia, blood triglycerides increased, diabetes mellitus
 
Psychiatric disorders

Common
 

Anxiety, nightmare, irritability
 
Nervous system disorders

Very common

Common
 

Peripheral neuropathy

Hypoaesthesia, disturbance in attention, tremor
 
Eye disorders

Common
 

Conjunctivitis
 
Ear and labyrinth disorders

Common
 

Vertigo
 
Respiratory, thoracic and mediastinal disorders

Common
 

Nasal congestion
 
Gastrointestinal disorders

Common
 

Pancreatitis, gastro-oesophageal reflux disease
 
Skin and subcutaneous tissue disorders

Common
 

Dry skin, eczema seborrhoeic, erythema, acne
 
Musculoskeletal, connective tissue and bone disorders

Common
 

Myalgia
 
Renal and Urinary Disorders

Common
 

Nephrolithiasis, haematuria
 
General disorders and administration site conditions

Very common

Common
 

Weight decreased

Influenza like illness, asthenia
 

c. Description of selected adverse reactions

Injection site reactions

Injection site reactions (ISRs) were the most frequently reported adverse reaction and occurred in 98% of the patients (Table 3). The vast majority of ISRs occurred within the first week of Fuzeon administration and were associated with mild to moderate pain or discomfort at the injection site without limitation of usual activities. The severity of the pain and discomfort did not increase with treatment duration. The signs and symptoms generally lasted equal to or less than 7 days. Infections at the injection site (including abscess and cellulitis) occurred in 1.5% of patients.

Table 3: Summary of individual signs/symptoms characterising local injection site reactions in studies TORO 1 and TORO 2 combined (% of patients)

  n=663
 
Withdrawal Rate due to ISRs
&nb